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.
Co-Investigator: Mario Pascual, M.D.

Cardiac Surgery

CRYPTICS

Clinical study to evaluate DMSO Cryopreserved Platelets for the treatment of acute hemorrhage in patients with platelets deficiency or platelet dysfunction undergoing cardiac surgery with cardiopulmonary bypass.

Patient Profile: Patients with platelets deficiency or platelet dysfunction undergoing cardiac surgery with cardiopulmonary bypass.

Clinical and Scientific Relevance: Cryopreservation of platelets is a promising technology that would allow smaller hospitals to provide platelet transfusions, reduce overall platelet wastage, and possibly produce better patient outcomes through more effective hemostasis. This study aims to compare them with the conventional liquid-stored platelets for the management of surgical bleeding. The study hypothesis is that cryopreserved platelets will be at least as effective as conventional liquid-stored platelets in the treatment of active bleeding due to surgery.

Principal Investigator: Niberto Moreno, M.D.

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

Activation Date: Pending

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., James Benenati, M.D., Guilherme Dabus, M.D., Italo Linfante, M.D.

Congestive Heart Failure

BMAD HFA

A prospective, observational, multinational study to evaluate the benefits of MICROCOR (μCorTM) in ambulatory decompensated heart failure.

Patient Profile: Patients with acute decompensated heart failure.

Clinical and Scientific Relevance: This is the first non-implantable, external, ambulatory monitoring device to remotely assess ejection fraction, heart rate and preload in patients with heart failure. It has been designed to assist in the overall monitoring of these patients, including medication changes, therapeutic outcomes and the prevention of hospitalizations.

Principal Investigator: Sandra Chaparro, M.D.

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

Activation Date: Pending

 

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: Pending

 

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

COLHEART-19

A prospective randomized evaluation to compare standard of care therapy with the effects of Colchicine on the short-term clinical outcomes in hospitalized COVID-19 patients with cardiac manifestations of the disease.

Patient Profile: Patients with COVID-19.

Clinical and Scientific Relevance: Conducted in conjunction with UCLA Medical Center, this is the largest study assessing the cardiac effects of Covid-19 and is the first IND filed by MCVI with the FDA.

Principal Investigator: Sandra Chaparro, M.D.

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

 

DARE-19

An international, multicenter, randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of Dapagliflozin in respiratory failure in patients with COVID-19.

Patient Profile: Patients with COVID-19.

Clinical and Scientific Relevance: Evaluates the effects of a known medication for diabetes and heart failure, on Covid-19 patients in respiratory failure.

Principal Investigator: Sandra Chaparro, M.D.

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

 

RLF-100

A phase 2b/3, multicenter, randomized, placebo controlled, double blind trial to evaluate the efficacy of RLF-100 in improving survival and reducing respiratory distress/requirement for mechanical ventilation in patients with critical COVID -19.

Patient Profile: Patients with COVID-19 with Respiratory Failure.

Clinical and Scientific Relevance: Evaluates the affect of intravenous RLF-100, Aviptadil, with aim to support pulmonary alveolar function, combat the cytokine-induced inflammation, improve blood oxygenation, and reduce mortality.

Principal Investigator: Javier Perez-Fernandez, M.D.

Clinical Research Coordinator: Ivette Cruz, APRN 786-596-2320

Activation Date: September 2020

 

FREEDOM

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: Pending

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.

Electrophysiology

Atrial Fibrillation Ablation QOL BHM & SMH

Prospective Non-blinded Study to Determine the Relationship between Ablation Therapy for Atrial Fibrillation (AF), Quality of Life and AF Specific Symptoms at 1 year, in Patients Undergoing AF Catheter Ablation at Baptist Hospital of Miami and South Miami Hospital.

Principal Investigator: Mario Pascual, M.D. (Active Follow-up)

Sub-Investigator: Ellie Haddad, 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

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.

 

Brain Aneurysm

COAST

COAST: Coiling of Aneurysms Smaller Than 5MM with Hypersoft. This is a prospective, single-arm, multi-center post-marketing ttudy. The Study will commence as a single phase, with an optional second phase to follow at the discretion of the sponsor. Up to 300 eligible Subjects with small (< 4.9 mm) intracranial aneurysms, who consent to Study participation, will be treated in Phase 1 with Microvention HyperSoft® 3D and HyperSoft® helical coils with or without balloon remodeling or stent assistance at the discretion of the treating physician. The operator, at his/her discretion, may choose to frame the aneurysm with HyperSoft® 3D or any other bare metal coil but must finish the remainder of the aneurysm with HyperSoft® 3D and/or HyperSoft® helical coils.

Principal Investigator: Guilherme Dabus, M.D. (Active Follow-up)
Co-investigator: Italo Linfante, M.D.

Peripheral Vascular Disease

BEST CLI – NIH study

Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia. The objective of the study is to learn about which therapy is more suitable for those patients who are candidates for both open surgery and endovascular treatment, and to provide information regarding cost effectiveness of the two different types of treatment.

Principal Investigator: James Benenati, M.D. (Active Follow-up)
Co-investigators: Barry Katzen, M.D., Constantino Peña, M.D., Alex Powell, M.D., Ripal Gandhi, M.D., Athanassios Tsoukas, M.D., Brian Schiro, M.D.

Structural Heart

PFO-PAS

Single arm, multi-center study to confirm the safety and effectiveness of the AMPLATZERTM PFO Occluder in the post approval setting.

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

Sub-investigator: Bernardo Lopez Sanabria, M.D.

 

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)

Co-investigators: Niberto Moreno, M.D., 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)

Co-investigators: Niberto Moreno, M.D., Lizardo Garcia Covarrubias, M.D., Bernardo Lopez Sanabria, M.D.

Vascular Disease

Detour II

This study evaluates the safety and efficacy of the Detour procedure technique for the revascularization of long occlusive femoro-popliteal arteries in patients with chronic, symptomatic lower limb ischemia.

This procedure is used as treatment for long (> 15 cm) blockages of the superficial femoral artery(SFA), using the company's stent grafts. The procedure creates an endovascular bypass that originates in the SFA, travels through the femoral vein, and then returns into the popliteal artery. This new pathway is designed to re-direct oxygen-rich blood flow around the obstructive diseased portion of the vessel, restoring this way the blood flow to the lower leg and foot of the patient with lower limb ischemia.

Principal Investigator: Alex Powell, M.D.
Co-Investigators: Constantino Pena, MD. Brian Schiro, MD. Ripal Gandhi, M.D.

 

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.., James Benenati, M.D.., Constantino Peña, M.D., Ripal Gandhi, M.D., Libby Watch, M.D., Brian Schiro, M.D.

 

EVAS 2

Prospective, Multicenter, Single Arm Safety and Effectiveness Confimatory Study of Endovascular Abdominal Aortic Aneurysm Repair using the Nellix System The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® Endo Vascular Aneurysm Sealing System for the endovascular repair of the infrarenal abdominal aortic aneurysms (AAA). Procedures will be performed per the instructions for use, and per institutional protocols and standard of care for endovascular aneurysm repair. As such, this study will evaluate the safety and effectiveness of the device system among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability.

Principal Investigator: James Benenati, M.D.., (Active Follow-up)
Co-Investigators: Barry Katzen, M.D.., Constantino Peña, M.D., Alex Powell, M.D., Ripal Gandhi, M.D., Libby Watch, M.D., Brian Schiro, M.D.

 

Arterial Disease

FMD Registry Fibromuscular Dysplasia International Registry

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

 

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)

 

RESIN registry

VICCGI1523 – Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Registry. The purpose of the study is to provide a real world view of clinical practice, patient outcomes, safety, and the comparative effectiveness of Y-90 treatment in patients with liver cancer.

Principal Investigator: Ripal Gandhi, M.D. (Active Follow-up)
Co-investigators: James Benenati, M.D. Alex Powell, M.D., Constantino Peña, M.D., Brian Schiro, M.D., Govindarajan Narayanan, M.D.