If you are interested in learning more about our clinical trial offerings, please contact Raul Herrera, M.D.

Call 786-596-3505

Cardiac Electrophysiology

PLEA trial

This study is designed to evaluate the safety and efficacy of the different types of ablation isolation techniques used to control persistent atrial fibrillation. The study tests the hypothesis whether either posterior wall isolation (PWI) with pulmonary vein isolation (PVI), or PWI plus left atrial appendage electrical isolation (LAAEI) with PVI; or PWI plus LAAEI plus coronary sinus isolation (CSI) with PVI is superior to the standard approach of PVI alone, in decreasing the incidence of the composite endpoint of all-cause mortality and all-atrial arrhythmia recurrences after the first ablation for persistent atrial fibrillation.

Principal Investigator: Juan Viles-Gonzalez, M.D.
Sub-Investigator: Mario Pascual, M.D.

Clinical Research Coordinator: Kenia Capdevilla, RN 786-596-4068

Activation Date: October 2020

Cardiac Surgery

STAR- T Trial

Prospective, Double-blinded, Randomized Multicenter Study of DrugSorb-ATR during CPB for the removal of ticagrelor (Brilinta) in patients undergoing cardiac surgery.

Patient Profile: Cardiothoracic surgery requiring CPB 48 hours from the last dose of ticagrelor:

  • CABG alone
  • Valve repair or replacement
  • Combination surgery (i.e., CABG + valve operation)
  • Aortic surgery

Prevention of bleeding. >500ml drainage reduction in European approval trials. Assessment of all adverse events at 30 days.

Principal Investigator: Charles Ma, M.D.

Clinical Research Coordinator: Yudmila Barbon-Tamayo, RN, 786-596-2320

Activation Date: May 2022

 

STAR- D Trial

Prospective, Double-blinded, Randomized Multicenter Study of DrugSorb-ATR during CPB for the removal of Apixaban and Rivaroxaban in patients undergoing cardiac surgery.

Patient Profile: Cardiothoracic surgery requiring CPB <36 hours from the last dose of Apixaban and Rivaroxaban:

  • CABG alone
  • Valve repair or replacement
  • Combination surgery (i.e., CABG + valve operation)
  • Aortic surgery

Prevention of bleeding. >500ml drainage reduction in European approval trials. Assessment of all adverse events at 30 days.

Principal Investigator: Charles Ma, M.D.

Clinical Research Coordinator: Yudmila Barbon-Tamayo, RN, 786-596-2320

Activation Date: May 2022

Carotid Artery Disease

CREST-2

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) and Crest-2 Registry (C2R).

Principal Investigator: Barry Katzen, M.D. (Active Enrollment)

Co-investigators: Athanassios Tsoukas, M.D., Ian Del Conde Pozzi, M.D., Guilherme Dabus, M.D., Italo Linfante, M.D.

Clinical Research Coordinator: Ivette Cruz, APRN 786-596-4746

Activation Date: June 2015

Congestive Heart Failure

PROACTIVE HF

A prospective, randomized, controlled, single blind, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients. The Cordella PA Sensor System is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient centered heart failure management.

Patient Profile: Patients with NYHA Class III Heart Failure.

Clinical and Scientific Relevance: This is an innovative, implantable hemodynamic monitoring system for heart failure patient’s remote management.

Principal Investigator: Sandra Chaparro, M.D.

Clinical Research Coordinator: Kenia Capdevilla, RN 786-596-2320

Activation Date: November 2020

 

BIOVENTRIX ALIVE

A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System for treatment of left ventricular aneurysm.

Patient Profile: Patients suffering from symptomatic heart failure referred for treatment of left ventricular antero-septal aneurysms/ scars.

Clinical and Scientific Relevance: This is a hybrid closed-chest procedure performed with a less invasive technology for the treatment of congestive heart failure (CHF) that reshapes the ventricular anatomy of the heart back to a more normal shape and size. Immediately after the procedure there is improvement in the left ventricular ejection fraction, there is an increase in blood flow and a remarkable improvement on CHF symptoms.

Principal Investigator: Ramon Quesada, M.D.

Clinical Research Coordinator: Maria Ardid 786-596-6258

Activation Date: April 2019

 

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.

Patient Profile: Patients with moderate to severe mitral regurgitation.

Clinical and Scientific Relevance: 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 786-596-6258

Activation Date: May 2019

COVID

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

Dilated Cardiomyopathy and Genetics

DCM Research Project

This is a collaborative study with Ohio State University, a family-based study aimed at identifying the genes responsible for dilated cardiomyopathy. 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. (Active Enrollment)

Co-Investigator: Hakop Hrachian-Haftvani, M.D.

Heart Disease Acute Coronary Syndrome (Coronary Artery Disease)

Acute Coronary Syndrome (Coronary Artery Disease)

CARES: Cardiac Arrest Registry to Enhance Survival

The CARES program is a collaborative effort of the Centers for Disease Control and Prevention (CDC), the American Heart Association (AHA) and the Emory University Department of Emergency Medicine. CARES is an ongoing model national out-of-hospital cardiac arrest surveillance registry that is capable of identifying and tracking out-of-hospital cardiac arrest events in a defined geographic area. Because CARES is a registry, not a research database, there is technically no specific study hypothesis, but the ultimate goal of CARES is to improve survival from sudden cardiac death. The registry is designed to help a local community identify who is affected, when and where cardiac arrest events occur, which elements of the system are functioning properly and which elements are not, and how changes can be made to improve cardiac arrest outcomes.

Principal Investigator: Tracey Patricoff, M.D.

Neurovascular Disease

HEMERA-1

This study evaluates the safety and efficacy of using a novel unique molecule that enhances the oxygen delivery capabilities of human hemoglobin, in patients with acute ischemic stroke diagnosed by head-computed tomography.

This is a complex molecule with enormous potential that in animal models has shown oxygen transfer and carbon monoxide-releasing capabilities. This study will evaluate the potential for this molecule to improve cerebral blood flow and oxygen extraction to vulnerable brain regions in patients at risk for cerebral ischemia after an acute ischemic stroke.

Principal Investigator: Italo Linfante, M.D.
Co-Investigator: Guilherme Dabus, M.D.

Clinical Research Coordinator: Yudmila Barbon-Tamayo, RN, 786-596-2320

Activation Date: March 2021

Oncology

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(DoR) and objective responses rate (ORR) in unrespectable hepatocellular carcinoma (HCC) patients.

Principal Investigator: Ripal Gandhi, M.D.

Clinical Research Coordinator: Ivette Cruz, APRN 786-596-4746

Activation Date: October 2021

 

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 786-596-4746

Activation Date: October 2021

Peripheral Vascular Disease

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

Sleep Medicine

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

 

Structural Heart

CHAMPION AF

Prospective, randomized, multi-center global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation. This is a New-Generation Watchman occlude Has High Closure Rates, Good Safety in patients with A. Fib who are not good candidates for long-term oral anticoagulation . Specifically, the new-generation occluder has a greater number of struts, a closed distal end to lessen the likelihood of perforation, dual-row anchors to reduce the risk of embolization, and reduced metal exposure. It can also be fully recaptured and repositioned.

Principal Investigator: Ramon Quesada, M.D.

Clinical Research Coordinator: Maria Ines Ardid, M.D. 786-596-6258

Activation Date: November 2021

 

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. This study will determine whether (on a background of guideline-directed medical therapy) a strategy of complete revascularization (involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions) is superior to a strategy of medical therapy alone, in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure in patients who have undergone successful elective transfemoral TAVR with a balloon expandable transcatheter (Edwards Lifesciences) heart valve. This study will determine whether, an initial strategy of complete revascularization is superior to an initial strategy of medical therapy for as all-cause mortality, stroke, bleeding, contrast associated kidney injury, and economic evaluation.

Principal Investigator: Ramon Quesada, M.D.

Clinical Research Coordinator: Maria Ines Ardid, M.D. 786-596-6258

Activation Date: May 2022

 

BIOVENTRIX

Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysm. The Revivent TC System is indicated for patients suffering from symptomatic heart failure referred for treatment of left ventricular antero-septal aneurysms/scars that are contiguous, and includes both anterior and septal components.

Principal Investigator: Ramon Quesada, M.D. (Active Enrollment)

Sub-investigator: Francisco Javier Jimenez-Carcamo, M.D.

 

SUMMIT

For the treatment of symptomatic, severe mitral regurgitation. The objective of this study is to evaluate the safety and effectiveness of the Tendyne Mitral Valve replacement system.

Principal Investigator: Ramon Quesada, M.D., (Active Enrollment)

Sub-investigators: Lisardo Garcia Covarrubias, M.D., Bernardo Lopez Sanabria, M.D.

 

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 Ines Ardid, M.D. 786-596-6258

Activation Date: October 2019

Vascular Disease

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.
Sub-Investigators: Ripal Gandhi, M.D., Andrew Niekamp, M.D., Brian Schiro, M.D., Alex Powell, M.D.

Clinical Research Coordinator: Jetsenea Coto 786-596-2421

Activation Date: March 2022

 

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. Adult 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, RN 786-596-4746

Activation Date: November 2021

 

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 post-approval 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: Mariana Perez de Alderet, RN 786-596-2058

Activation Date: May 2022

 

RESCUE

A prospective, non-randomized, multi-center study looking to demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism. New innovative endovascular catheter with expanded lumen allows larger infusions and potentially better outcomes with lower doses of r-tPA. Approved for DVT, not yet approved for PE.

Principal Investigator: Ripal Gandhi, M.D.

Clinical Research Coordinator: Kenia Capdevilla, RN 786-596-4068

Activation Date: December 2020

 

Abdominal Aortic Aneurysm

Gore Excluder AAA

Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms. Prospective, multicenter, non-randomized clinical study with two parallel substudies 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.

Principal Investigator: Alex Powell, M.D. (Active Enrollment)
Co-investigators: Barry Katzen M.D., Constantino Peña, M.D., Ripal Gandhi, M.D., Libby Watch, M.D., Brian Schiro, M.D.

 

Arterial Disease

SYNC VISION

Prospective, Single Operator, Control Study to Evaluate the Correlation of the SyncVision Precision Guidance System with the Clinical Decisions Made During Percutaneous Coronary Intervention. The overall objective of this study is to compare the evaluations obtained during 10 PCI cases in a room with the SyncVision system at the Miami Cardiac and Vascular Institute (MCVI) and the evaluations obtained during 10 PCI cases in a room without the SyncVision system at MCVI.Interventions at the Miami Cardiac and Vascular Institute in Baptist Hospital of Miami.

Principal Investigator: Ramon Quesada, M.D. (Active Enrollment)

Clinical Research Coordinator: Kenia Capdevilla, RN 786-596-4068

Activation Date: December 2018