Cardiovascular Clinical Research Trials

INTEGRA-D

Assessment of the Safety and Efficacy of the Optimizer Integra D System.  An implantable cardiac device system that combines cardiac contractility modulation and implantable cardioverter defibrillator modules into one device.  

Principal Investigator:  Mario Pascual, M.D.
Clinical Coordinator:  Margie McKercher, CCRC  786-595-8075

HEAL-IST

Evaluation of the safety and effectiveness of a hybrid sinus node sparing ablation procedure. Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia (IST). This Investigational Device will be used in conjunction with a commercially available endocardial catheter for mapping and/or ablation for the treatment of symptomatic drug refractory or drug intolerant IST.

Principle Investigator: Steven Hoff, M.D.
Clinical Coordinator: TBA

 

LeAAPs Trial

Left Atrial Appendage Exclusion for Prophylactic Stroke Reductions Trial.  A prospective, concurrent, randomized control (1:1), blinded, multi-center, multinational, to assess the safety and effectiveness of  the AtriClip® LAA Exclusion System.  The AtriClip® LAA Exclusion System (“AtriClip”) is indicated for exclusion of the heart’s left atrial appendage performed under direct visualization and in conjunction with other cardiac surgical procedures for the prevention and/or reduction of  ischemic stroke and systemic embolism in patients who are at risk of these events.

Principle Investigator:  Steven Hoff, M.D.
Clinical Coordinator:  Yudmila Barbon Tamayo, RN  786-527-9101; ASCOM 786-594-9997

 

CREST-2

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) and Crest-2 Registry (C2R).  The study aims to clarify what is the most effective approach for carotid revascularization in the primary prevention of stroke.

Principal Investigator: Barry T. Katzen, M.D.
Clinical Research Coordinator: Ivette Cruz, APRN  786-527-9063; ASCOM 786-594-9978

AIM HIGHer

A multicenter, multi-national, randomized, quadruple-blind, sham controlled, 2-part, embedded IDE clinical trial Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction. The Optimizer Smart Mini System addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative options despite maximized medical therapy for HF. 

Principle Investigator: Sandra Chaparro, M.D.
Clinical Research Coordinator: Ruben Dominguez, CRC 786-595-8078

 

ANALOG CPM

Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients with Chronic Heart Failure.  The Analog CPM system is a multimodal device that monitors and manages chronic heart failure patients in their homes.

Principle Investigator: Jonathan Fialkow, M.D.
Clinical Research Coordinator: Margie McKercher, CCRC 786-595-8075

 

Cordio HearO™

An international, multicenter, observational, single-arm, blinded study to assess performance of the Cordio HearO™  System. The Cordio HearO™ is a mobile app that remotely monitors CHF patients by detecting changes in the patients' recorded voice relative to a baseline, under the supervision of a health care practitioner, in the home environment, for the recording, storage, transmission, display and analysis of a predefined set of voice utterances. This approach provides a more continuous assessment of the patient’s health status as technology-based monitoring provides the clinical data between in person visits for remote disease management.

Principle Investigator: Sandra Chaparro, M.D. Clinical Research Coordinator: Margie McKercher, CCRC 786-595-8075

 

EMPOWER

A prospective, randomized, blinded clinical trial to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation associated with heart failure.  This is a new device for the treatment of Mitral regurgitation that once used immediately improves symptoms.

Principal Investigator: Ramon Quesada, M.D.
Clinical Research Office: Maria Ardid, 786-527-9731; ASCOM 786-594-9967

 

PROACTIVE HF

FREEDOM COVID

A prospective, multicenter, open-label, randomized controlled trial to evaluate the safety and effectiveness of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19.

Patient Profile: Patients with COVID-19.

Clinical and Scientific Relevance: Evaluates the effects of a known anticoagulation medication, on patients with Covid-19.

Principal Investigator: Sandra Chaparro, M.D.

Clinical Research Coordinator: Research Office, 786-596-2320

Activation Date: January 2021

DCM Research Project

This is a collaborative endeavor with Ohio State University, a family-based study aimed at identifying the genes responsible for dilated cardiomyopathy (DCM). The purpose of this study is to identify gene changes that cause DCM and the gene differences that influence the development and severity of DCM.

Principal Investigator: Francisco Javier Jimenez-Carcamo, M.D. 
Clinical Research Office: 786-662-8467

ISO-SHOCK

A multi-center, prospective randomized (1:1) pilot and feasibility study to evaluate the safety and feasibility of supersaturated oxygen (SSO2) therapy delivered for 60 minutes selectively into the culprit coronary artery of patients presenting with ST elevation myocardial infarction and cardiogenic shock treated using a shock protocol. The TherOx DownStream System is indicated for the preparation and delivery of SSO2 Therapy to targeted ischemic regions perfused by the patient’s coronary artery immediately following revascularization by means of percutaneous coronary intervention, in qualifying patients experiencing cardiogenic shock as a consequence of ST elevation myocardial infarction treated concurrently with a mechanical circulatory support device.

Principle Investigator: Ramon Quesada, M.D.
Clinical Research Coordinator: Maria Ardid, 786-527-9731;  ASCOM 786-594-9967

 

LIBREXIA-ACS

RADIANCE-CAP

A non-randomized, 2-cohort study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, in two populations of hypertensive subjects. Prior to procedure subjects will be hypertensive despite the prescription of antihypertensive medications.   
    
Principle Investigator: Ian Del Conde, M.D.
Clinical Research Coordinator: Ruben Dominguez, CRC 786-595-8078

GORE Excluder AAA

A prospective, multicenter, non-randomized clinical study with two parallel sub studies designed to evaluate the safety and effectiveness of the CEXC Device for the treatment of infrarenal AAA in patients with Short Neck and highly angulated infrarenal aortic necks. The study aims to implant the first of its kind endoprosthesis without the need of open surgical repair when used for optimal seal in the treatment of infrarenalabdominal aortic aneurysms.

Principal Investigator: Alex Powell, MD
Clinical Research Coordinator: Ivette Cruz, APRN 786-527-9063; ASCOM 786-594-9978

 

LIBERTY

A prospective, First in Man, US-based multi-center, single arm, non-randomized, study to assess the clinical capabilities and user performance of the LIBERTY® Robotic System in Peripheral Vascular Interventions.  A new approach to remote catheter manipulation that minimizes complexity and cost as compared to currently available systems.

Principle Investigator: Ripal Gandhi, M.D.
Clinical Coordinator: TBA

 

LOW PROFILE COVERED STENT

A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD Low Profile Vascular Covered Stent for the treatment of stenosis and occlusion in the common and/or external iliac artery and the superficial femoral artery (SFA)/proximal popliteal artery (PPA).

Principle Investigator: Ripal Gandhi, M.D.
Clinical Coordinator: Kenia Capdevilla, RN  786-527-9134; ASCOM 786-594-9408

 

MOTIV BTK

A prospective, multicenter, single blind, randomized, controlled clinical trial to evaluate the safety and efficacy of the MOTIV scaffold for the treatment of infrapopliteal lesions in patients with critical limb ischemia by comparison with standard balloon angioplasty.

Principle Investigator: Alex Powell, M.D.
Clinical Coordinator: Kenia Capdevilla, RN  786-527-9134; ASCOM 786-594-9408

 

DEEPER REVEAL

A prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System). The Bare Temporary Spur Stent System is intended for use in the infrapopliteal arteries ranging in diameter from 2.5mm to 4.5mm for the treatment of critical limb ischemia (CLI).

Principle Investigator: Constantino Pena, M.D.
Clinical Coordinator: Kenia Capdevilla, RN  786-527-9134; ASCOM 786-594-9408

 

BOLT

A prospective, single-arm, multi-center study of patients with deep vein thrombosis to evaluate the safety and efficacy of the Indigo™ Aspiration System in patients with deep vein thrombosis.

Principle Investigator: Brian Schiro, M.D.
Clinical Coordinator: Jetsenea Coto, CCRC 786-596-2421

 

GORE Excluder

A prospective, multicenter, non-randomized clinical study with two parallel sub studies designed to evaluate the safety and effectiveness of the CEXC Device for the treatment of infrarenal AAA in patients with Short Neck and highly angulated infrarenal aortic necks.

Principle Investigator: Alex Powell, M.D.
Clinical Coordinator: Ivette Cruz, APRN 786-596-4746

 

JAGUAR

Objective Analysis to GaUge EVAR Outcomes Through Randomization. Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints.

Principle Investigator: Constantino Pena, M.D.
Clinical Coordinator: David Fernandez 786-596-5392

 

EVOLVE 

A prospective, multi-center, single-arm, open-label, international clinical study for endovascular treatment of wide-neck aneurysms.  This clinical trial evaluates  the safety and effectiveness of  Stryker Surpass Evolve™ Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring and located on the internal carotid artery (ICA) or its branches.

Principle Investigator: Guilherme Dabus, M.D.
Clinical Research Coordinator: Yudmila Burbon Tamayo, RN  786-527-9101; ASCOM 786-594-9997

 

SEAL IT

Saccular Endovascular Aneurysm Lattice System for the intravascular minimally invasive treatment of saccular intracranial aneurysms. Increased flow diversion and intrasaccular stasis with a double layer device for faster aneurysmal thrombosis and occlusion than competitors. Soft compliant device for better aneurysm fit and sizing.

Principle Investigator: Italo Linfante, M.D.
Clinical Coordinator: Yudmila Barbon Tamayo, RN  786-527-9101; ASCOM 786-594-9997

 

DOORWAY 90 Study

A prospective, multicenter, open-label single arm study evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres ™ Y-90 resin microspheres on duration of response and objective responses rate in unrespectable hepatocellular carcinoma (HCC) patients.  The objective of this pivotal study is to evaluate the safety and effectiveness of SIRT using SIRSpheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer stage A, B1, B2, and C.

Principal Investigator: Ripal Gandhi, M.D.
Clinical Research Coordinator: Ivette Cruz, APRN  786-527-9063;  ASCOM 786-594-9978

 

HOPE4LIVER CSP1427

A single-arm, non-randomized prospective trial using the HistoSonics System for treatment of primary and metastatic liver tumors using histotripsy (#HOPE4LIVER US). Patient Profile: Patients with primary or metastatic liver tumors. Clinical and Scientific Relevance.  The objective of this trial is to evaluate the safety and efficacy of the HistoSonics System for the treatment of primary or metastatic tumor located in the liver.

Principal Investigator: Govindarajan Narayanan, M.D.
Clinical Research Coordinator: Ivette Cruz, APRN  786-527-9063; ASCOM 786-594-9978

 

IMMUNOPHOTONICS  IP-110-622

Intratumoral injection of IP-001 following thermal ablation in patients with advance solid tumors. A multicenter 1a/2b trial in colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma patients.  The therapeutic approach taken by this trial is different from those already used in current practice and chemotherapy is still the standard treatment for these patients as it can offer patients a therapeutic benefit after failure of current standard chemotherapy and immunotherapy.

Principal Investigator: Govindarajan Narayanan, M.D.
Clinical Research Coordinator: TBA

 

STRIDE ALI

A post-market, real world, prospective, single-arm, multi-center study looking at patients that present with Lower Extremity Acute Limb Ischemia LE ALI who are eligible for mechanical thrombectomy using the Indigo Aspiration System. The Indigo Aspiration System is a medical device approved by the FDA to treat LE ALI. This study will collect real world outcomes data from the daily use of the device.

Principal Investigator: Alex Powell, M.D.
Clinical Research Coordinator: Kenia Capdevilla, RN, 786-596-4068
Activation Date: September 2020

PEERLESS

A prospective, multicenter, randomized controlled trial of the FlowTriever System compared to CDT for acute intermediate-high-risk PE, and includes a non-randomized cohort for subjects with an absolute contraindication to thrombolytics. Primary objective is to compare the clinical outcomes of patients treated with the FlowTriever System versus Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute intermediate-high-risk pulmonary embolism (PE).

Principal Investigator: Ripal Gandhi, M.D.
Clinical Research Coordinator: Jetsenea Coto, CCRC / 786-527-9480; ASCOM 786-594-9424

 

PE-TRACT

Pulmonary Embolism – PE Thrombus Removal with Catheter-Directed Therapy vs. Medical Therapy alone.  To determine whether patients with submassive PE who are treated with catheter-directed therapy (includes catheter mechanical thrombectomy and catheter directed lysis plus medical therapy) have better cardiopulmonary health and quality of life in the year following PE than patients treated with medical therapy alone.

Principle Investigator: Ripal Gandhi, M.D.
Clinical Research Coordinator: Kenia Capdevilla, RN  786-527-9134; ASCOM 786-594-9408

 

STRIKE PE

A prospective, multicenter study of the Indigo aspiration system seeking to evaluate the long-term safety and outcomes of treating pulmonary embolism. There are limited studies with long-term and patient-centric outcomes. The results of this study will provide additional data, longer term safety and patient-centric functional outcomes on the use of the Indigo Aspiration System for mechanical aspiration thrombectomy in acute PE patients.

Principal Investigator: Brian Schiro, M.D.
Clinical Research Coordinator: Kenia Capdevilla, RN  786-527-9134; ASCOM 786-594-9408

 

SUPRA Sleep Trial – Study Using Negative Pressure to Reduce Apnea (SUPRA)

This is a multi-center, prospective, single-arm, observational interventional trial to determine the safety and effectiveness of the aerSleep® II System. The aerSleep® II System is an integrated continuous external negative pressure (cNEP) system to treat moderate to severe obstructive sleep apnea (OSA) in spontaneously breathing subjects intolerant to continuous positive airway pressure (CPAP) therapy. Enrolled subjects who successfully acclimate to the aerSleep® II System, will use the device nightly in the home setting for 24 weeks.

Principal Investigator: Harneet Walia, MD, FAASM
Sub-investigator: Sub Investigator: Wendy Cardenas, ARNP

 

HEMERA-1 EXTENSION

This is a study extension (Part II), of the existing Randomized, Phase 1, multicenter clinical trial to Assess the Safety of PP-007 (PEGylated Carboxyhemoglobin, Bovine) in Subjects with Acute Ischemic Stroke. This is the first of its kind hemoglobin compound that in animal models has proven to protect the brain from ischemic stroke with markedly decrease infarct volume and neurological deficits. The molecule is a polymeric hemoglobin that stimulates oxygenation and promotes vasodilation in the ischemic areas, including the Penumbra.

Principle Investigator: Italo Linfante, M.D.
Clinical Coordinator: Yudmila Barbon Tamayo, RN  786-527-9101; ASCOM 786-594-9997

 

SUMMIT MAX

A Prospective, randomized (1:1), controlled, interventional clinical trial to evaluate the safety and effectiveness of the Route 92 Medical MonoPoint® Reperfusion System for aspiration embolectomy in acute ischemic stroke patients.  The Route 92 Medical Reperfusion System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid or middle cerebral arteries within 8 hours of symptom onset.

Principle Investigator: Guilherme Dabus, M.D.
Clinical Research Coordinator: Yudmila Barbon Tamayo, RN 786-527-9101; ASCOM 786-594-9997

 

CONFORM

CONFORM study is a pivotal trial that evaluates the safety and effectiveness of the Conformal CLAAS System for left atrial appendage occlusion.  The Conformal CLAAS® Device is a permanent implant designed to occlude the left atrial appendage (LAA) to eliminate blood flow into and clot passage from the LAA.  The CLAAS implant is intended to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who are (1) at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores and are recommended for oral anticoagulation (OAC) (Coumadin or DOAC) therapy; (2) deemed by their physician to be suitable for OAC; (3) and have an appropriate rationale to seek a non-pharmacological alternative to OAC, considering the safety and effectiveness of the device compared to OAC• Have an appropriate rationale to seek a non-pharmacological.

Principle Investigator: Ramon Quesada, M.D.
Clinical Research Coordinator: Maria Ardid, 786-527-9731; 786-594-9967

 

COMPLETE TAVR

A randomized, comparative effectiveness study of staged complete revascularization with percutaneous coronary intervention to treat coronary artery disease vs. medical management alone in patients with symptomatic aortic valve stenosis undergoing elective transfemoral transcatheter aortic valve replacement.

Principal Investigator: Ramon Quesada, M.D.
Clinical Research Coordinator: Maria Ardid, 786-786-527-9731; ASCOM 786-594-9967

 

TRILUMINATE

A prospective, multicenter, randomized, controlled, clinical trial of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation who have been determined by the sites local heart team to be at immediate or greater estimated risk for mortality with tricuspid valve surgery. This Endovascular Tricuspid valve repair technology allows for the improvement of clinical outcomes in symptomatic patients with severe tricuspid regurgitation, who are at intermediate or greater estimated risk for mortality or morbidity with a tricuspid valve surgery.

Principal Investigator: Ramon Quesada, M.D.
Clinical Research Coordinator: Maria Ardid, 786-527-9731; ASCOM 786-594-9967

 

SUMMIT TENDYNE

A prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, moderate-to-severe or severe mitral regurgitation.  This investigational device is the first and only minimally invasive Mitral Valve Replacement system that can be repositioned and fully retrieved, allowing precise device placement during implantation and better clinical outcomes on the treatment of mitral regurgitation.

Principal Investigator: Ramon Quesada, M.D.
Clinical Research Coordinator: Maria Ardid, 786-527-9731; ASCOM 786-594-9967

 

AltaValve

This study uses a transeptal approach to the Left Atrium to anchor an innovative flexible Mitral Valve device for its repair and/or replacement in patients with severe symptomatic MR unsuitable for TEER or Surgery.

Principal Investigator: Ramon Quesada, M.D. 
Clinical Research Coordinator: Maria Ardid,786-527-9731; ASCOM 786-594-9967

 

BOLT DVT

A prospective, single-arm, multi-center study of patients with deep vein thrombosis to evaluate the safety and efficacy of the Indigo™ Aspiration System in patients with deep vein thrombosis (DVT).  Study objective is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis  (DVT) who are eligible for treatment.

Principal Investigator: Constantino Pena, M.D.
Clinical Research Coordinator: Jetsenea Coto, CCRC 786-527-9480; ASCOM 786-594-9424

 

SAVVE

A prospective, non-blinded, single-arm multi-center pivotal study of the Hancock Jaffe VenoValve. The valve is a monocuspid biological component mounted in a rigid supporting metal frame. The biological component comprises of a porcine aortic valve noncoronary leaflet as the functional component of the VenoValve with a section of aorta and a porcine mitral valve anterior leaflet stitched together as the supporting wall. Adults with chronic, axial deep venous reflux (CEAP Class C4b, C4c, C5 or C6) secondary to previous deep venous thrombosis (post-thrombotic syndrome) or primary reflux who have failed at least 3 months of standard care including compression therapy, and in C6 patients, wound care. All patients will receive optimized care (e.g., appropriate medications, compression therapy) throughout the study.

Principal Investigator: Michele Taubman, M.D.
Clinical Research Coordinator: Ivette Cruz, APRN 786-527-9063; ASCOM 786-594-9978

 

JAGUAR

Objective Analysis to Gauge EVAR outcomes through randomization. Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Objective of this study is to collect safety, performance, effectiveness, and neck dilatation data on Alto Abdominal Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms and evaluate real-world outcomes in comparison to commercially available comparator devices.

Principal Investigator: Constantino Pena, M.D.
Clinical Research Coordinator: David Fernandez, CRC 786-527-9430; ASCOM 786-594-8320

 

STAAABLE Nectero Trial

Evaluation of the use of the local delivery of a single dose of  PGG in the endovascular treatment of infra-renal, Mid-Sized AAA for clinical stabilization.  Elastin and collagen provide the necessary structural stability and flexibility of the aorta over the lifetime of an individual, and both elastin and collagen are degraded over the course of AAA development and its progressive degradation. When exposed to PGG, the hydrophobic “tentacles” form “pseudo” crosslinks with the hydrophobic regions of the remaining elastin, re-establishing elastic properties.

Principle Investigator: Libby Watch, M.D.
Clinical Coordinator: Ivette Cruz, APRN 786-527-9063; ASCOM 786-594-9978