Clinical Trials

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Current Clinical Trials

ALIVE Trial (NCT02931240)

Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms (ALIVE)

A prospective, multi-center, dual-arm pivotal study with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in active control group.

PI: Samar Sheth, MD

ANTHEM-HFrEF Pivotal Study (NCT03425422)

Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure With Reduced Ejection Fraction

A multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy with the VITARIA system in patients with symptomatic heart failure and reduced ejection fraction.

PI: Joggy George, MD

ARRAY Study (NCT03439514)

A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation

PI: Emerson Perin, MD, PhD

CardiAMP™ Heart Failure Trial (NCT02438306)

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Post Myocardial Infarction Heart Failure

A clinical trial for patients suffering from heart failure after a previous heart attack.

PI: Emerson Perin, MD, PhD
SPONSOR: BioCardia, Inc

CHIEF HF Study (NCT04252287)

Canagliflozin: Impact on Health Status, Quality of Life, and Functional Status in Heart Failure

The purpose of this study is to determine the superiority of the effectiveness of canagliflozin 100 milligram (mg) daily versus placebo in participants with symptomatic heart failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS).

PI: Emerson Perin, MD, PhD
Sponsor: Janssen Research & Development, LLC

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CONCERT-HF (NCT02501811) | Enrollment Closed

This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cardiac stem cells (CSCs) both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.

Cross-Seal™ IDE Trial (NCT03756558)

Cross-Seal™IDE Trial:  Prospective, Multi-Center, SingleArm Studyof theCross-Seal™ Suture Mediated Vascular Closure Device System

This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath. The Cross-Seal device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (8‐18F ID) interventional devices. The function of Cross-Seal is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.

PI: Zvonimir Krajcer, MD
SPONSOR: Terumo Medical Corporation

cVAD Study

Ongoing, observational, prospective, multicenter, records review study of routine clinical care and outcomes for patients who received support from one or multiple ABIOMED, Inc. hemodynamic support devices in routine clinical care.

PI: Andrew Civitello, MD

DREAM-HF 1 (NCT02032004) | Enrollment Closed

The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

PI: Emerson Perin, MD, PhD

GORE EXCLUDER (NCT02489539)

Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

A study to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta.

PI: Zvonimir Krajcer, MD
SPONSOR: W.L.Gore & Associates

 

Heart FID (NCT03037931)

Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure with Iron Deficiency

PI: Reynolds Delgado, MD

MSCs vs Standard of Care in Cardiomyopathy (NCT02962661)

Randomized 3-Arm Trial with Standard of Care Alone vs either Intravenous Infusion or Transendocardial Injection of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) plus Standard of Care in Patients with Anthracycline-Associated Cardiomyopathy 2015-0835

To demonstrate the safety of allogeneic human mesenchymal stem cells (hMSCs) administered by intravenous infusion and transendocardial injection in patients with left ventricular (LV) dysfunction and heart failure secondary to chemotherapy with anthracyclines.

MDA Study PI: Amanda Olson, MD
THI PI: Emerson Perin, MD, PhD
SPONSOR: M.D. Anderson Cancer Center
COLLABORATOR: Texas Medical Center

LESS-VT | FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study (NCT03490201)

This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.

PI: Nilesh Mathuria
SPONSOR: Abbott

SENECA (NCT02509156) | Enrollment Closed

The primary purpose of this study is to examine the safety and feasibility of delivering allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced cardiomyopathy (AIC).

The secondary purpose of this study is to obtain preliminary evidence for therapeutic efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV dysfunction secondary to AIC.

Solve CRT (NCT02922036)

Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients (SOLVE CRT)

This study is a prospective, multi-center, randomized, controlled, double blinded, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.  The WiSE-CRT System is an implantable cardiac pacing system capable of delivering pacing energy to the left ventricle of the heart without using a pacing lead.

PI: Nilesh Mathuria, MD
SPONSOR: EBR Systems

PORTICO IDE (NCT02000115)

The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.