Clinical Trials

BACKBEAT

A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a previously implanted dual-chamber Medtronic pacemaker.

Principal Investigator: Juan Viles-Gonzalez, M.D.
Clinical Coordinator: Margie McKercher, CCRC 786-595-8075

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: Yanet Alfonso, RN 786-594-9406

 

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: Yanet Alfonso, RN 786-594-9406

 

TQJ230

A randomized double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) in US Black/African American & Hispanic patient populations with elevated Lp(a) and established atherosclerotic cardiovascular disease.

Principal Investigator: Adedapo Iluyomade, M.D.
Clinical Research Coordinator: Ruben Dominguez, CRC 786-595-8078

DCM Research Project

This is a collaborative endeavor with Ohio State University. A family based study that aims to identify the genes responsible for dilated cardiomyopathy (DCM).

Principal Investigator: Francisco Javier Jimenez-Carcamo, M.D.
Clinical Coordinator: Luella Reyes, MSN 786-527-7023

AIM HIGHer

A multicenter, multinational, 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 do not benefit sufficiently 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

 

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

 

HERMES

Effects of Ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.

Principal Investigator: Adedapo Iluyomade, M.D.
Clinical Research Coordinator: Margie McKercher, CCRC 786-595-8075

 

PROACTIVE HF II

A prospective, multicenter, open label, randomized controlled clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II - III heart failure patients.

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

 

LIBREXIA-ACS

A phase 3, randomized, double-blind, placebo-controlled, event-driven study to demonstrate the efficacy and safety of Milvexian, an oral factor XIa inhibitor, after a recent acute coronary syndrome. Milvexian is an orally administered anticoagulant for the prevention and treatment of atherothrombotic and thromboembolic disorders.

Principle Investigator: Nish Patel, M.D.
Clinical Research Coordinator: Ambulatory Research Coordinators 786-595-8077

 

MERCK 0616-015

A phase 3, randomized, placebo-controlled clinical study to evaluate the efficacy and safety of MERCK 0616 in reducing major adverse cardiovascular events in participants with high cardiovascular risk factors. Even though there is documented evidence of the benefits of lowering LDL-C with respect to cardiovascular outcomes, as well as the availability of several proven LDL-C lowering therapies, a vast number of patients with hypercholesterolemia are not at the recommended LDL-C levels per clinical guidelines.

Principle Investigator: Jonathan Fialkow, M.D.
Clinical Research Coordinator: Ambulatory Research Coordinators 786-595-8077

 

SELUTION

A prospective randomized, single-blind, multicenter study to assess the safety and effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the treatment of subjects with in-stent restenosis. Randomized 1:1 vs. DES or POBA. This study provides a unique cell adherent technology with smoother balloon surface allowing for better deliverability.

Principle Investigator: Ramon Quesada, M.D.
Clinical Coordinator: Kenia Capdevilla, RN 786-527-9134; Maria Ines Ardid, M.D.

 

ACCESS PVI

A prospective, first in man, US based multicenter, 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: Adys Morejon, CRC 786-594-9952

 

AGILITY

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

 

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.

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

 

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; ASCOM 786-594-4832

 

MAGICAL TOUCH BTK

Randomized controlled trial of first Sirolimus coated balloon versus standard balloon angioplasty in the treatment of below the knee arterial disease.

Principle Investigator: Constantino Pena, M.D.
Clinical Coordinator: TBA

 

ACCLAIM

A prospective multicenter study that aims to establish microwave ablation as the preferred curative therapy for selected colorectal liver metastases (CLM) that can be ablated with sufficient margins and minimal morbidity.

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

 

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

 

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: Kenia Capdevilla, BSN 786-594-9408

 

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

 

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: Kenia Capdevilla, RN 786-527-9134; ASCOM 786-594-9408

 

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

 

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

 

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

 

Prospective FMD Registry

Fibromuscular dysplasia is not commonly recognized and is less common than other diseases seen by specialty physicians. Patients often have difficulty finding physicians who have experience in treating fibromuscular dysplasia. This lack of medical knowledge leads to a tremendous amount of anxiety on the part of the patient and their family members. The goal of this Prospective FMD Registry is to understand the prevalence and natural history of FMD and its vascular complications. It aims to not only provide a better understanding of the disease, but to allow for future research opportunities.

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