Cardiovascular Clinical Research Trials | Miami Cardiac & Vascular Institute
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Cardiovascular Clinical
Research Trials
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Cardiovascular Clinical Research Trials

If you are interesting in learning more about our clinical trial offerings,
please contact Raul Herrera, M.D. at 786-596-3505 or email

 

CAROTID ARTERY DISEASE

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

Principal Investigator: Barr​y 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.

HEART 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.

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

EP Predictors of complete heart block​

Prospective evaluation of post procedural AH and HV interval changes to determine association with new onset of Atrio-Ventricular Block in patients undergoing Transcatheter Aortic Valve Replacement at the Miami Cardiac and Vascular Institute in Baptist Hospital of Miami. ​

Principal Investigator: Ramon Quesada, M.D., Mario Pascual, M.D. (Active Enrollment)
Co-investigators: Niberto Moreno, M.D., Lizardo Garcia Covarrubias, M.D., Bernardo Lopez Sanabria, M.D.

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 Enrollment)
Sub-investigator: Ellie Haddad, 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.

 

REDUCE LAP HF II

Multicenter, prospective, randomized controlled, single (patient) blinded trial, with Non-implant Control Group for patients with a diagnosis of heart failure with preserved or mildly reduced ejection fraction.

The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction ≥40% and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).

Principal Investigator: Ramon Quesada, M.D. (Active Enrollment)
Co-Investigator: Francisco Javier Jimenez-Carcamo, M.D.

Aortic Valve Leaflet Tissue

Aortic valve leaflet collection following surgical resection. Perform in vitro studies on cells isolated from valvular tissues, histopathological analyses of frozen tissue sections, and ex vivo experiments on intact tissue specimens to assess neural activity within aortic valves and resultant effects on pathological remodeling with the aortic valve tissues. This study is in collaboration with FIU Medical School.

Principal Investigator: Niberto Moreno, M.D. (Active Enrollment)
Co-Investigator: Lisardo Garcia-Covarrubias, M.D., Joshua Hutcheson, PHD

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)
Niberto Moreno, M.D., Lizardo Garcia Covarrubias, M.D., Bernardo Lopez Sanabria, M.D.

NEUROVASCULAR DISEASE

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 Enrollment)
Co-investigator: Italo Linfante, M.D.

TIGER

Treatment with Intent to Generate Endovascular Reperfusion. This study is a US and EU, multicenter, single arm, prospective IDE study to evaluate the safety (defined as all-cause mortality) and effectiveness of the Tigertriever Revascularization Device in Acute Ischemic Stroke (AIS) patients ineligible for IV t-PA treatment or who fail IV t-PA therapy. The objective of the TIGER Study is to evaluate the safety and effectiveness of the Tigertriever device in restoring blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke due to a large vessel occlusion (LVO).

Principal Investigator: Guilherme Dabus, M.D. (Active Enrollment)
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 Enrollment)
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.

VASCULAR DISEASE

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 Enrollment)
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 Enrollment)
Co-investigators: James Benenati, M.D. Alex Powell, M.D., Constantino Peña, M.D., Brian Schiro, M.D., Govindarajan Narayanan, M.D.

FE Enhanced MRA

Prospective, Non-blinded, Observational Evaluation of the use of Ferumoxytol-enhanced MRA for cardiovascular imaging. Single Center, Multiple Operators, Prospective Observational, Non- blinded Study Assessing the feasibility, diagnostic performance and economical evaluation of using Ferumoxytol for the detection and exclusion of hemodynamically significant diagnostic enhanced MRA in patients requiring Cardiovascular Imaging at Baptist Hospital of Miami.

Principal Investigator: Constantino Peña, M.D. (Active Enrollment)

PULMONARY DISEASE

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry
An observational multi-center, non-interventional, prospective registry that will collect information regarding the natural history, health care interactions, and participant reported questionnaire data to assess quality of life of IPF participants, and the methods of treatment of participants with a diagnosis of IPF established at the enrolling centers. In addition, blood samples will be collected and banked for future research projects.

Principal Investigator: Jeremy Tabak, M.D. (Active Enrollment)

OBSTRUCTIVE SLEEP APNEA

Inspire® Upper Airway Stimulation (UAS) System: Post Approval Study
A multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. The purpose is to obtain additional long-term safety and efficacy data on the use of Inspire therapy in a post-market environment for the treatment of moderate to severe Obstructive Sleep Apnea (OSA) (20≤AHI≤65) in subjects who have been confirmed to fail or cannot tolerate positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BPAP] machines) and who do not have a complete concentric collapse at the soft palate level.

Principal Investigator: Jeremy Tabak, M.D. (Active Enrollment)

Updated 10/16/2019​