ACTIVE STUDIES
RESPONDER-HF- NCT05425459 PI: Douglas Ensley, MD
Prospective, Multicenter, randomized, sham controlled, double-blinded clinical trial, with 1:1 randomization. Purpose is to evaluate clinical efficacy of Corvia atrial shunt in symptomatic HF patients with preserved (HFpEF) or mildly-reduced ejection fraction (HFmrEF) with elevated left atrial pressure.
Study Details | NCT05425459 | RESPONDER-HF Trial | ClinicalTrials.gov
EMPOWER- NCT03142152 PI: Douglas Ensley, MD
Prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR). Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio.
Study Details | NCT03142152 | The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR | ClinicalTrials.gov
INTEGRA-D- NCT05855135 PI: Douglas Ensley, MD
Prospective, Multicenter, single arm clinical trial designed to evaluate the safety and efficacy of the OPTIMIZER® Integra CCM-D System, a combined cardiac contractility modulation and implantable cardioverter defibrillator device, in subjects with Stage C or D heart failure and reduced ejection fraction (LVEF ≤40%) who remain symptomatic despite guideline-directed medical therapy (GDMT) and are not candidates for cardiac resynchronization therapy (CRT).
Researcher View | NCT05855135 | Assessment of Combined CCM and ICD Device in HFrEF | ClinicalTrials.gov
AIM-HIGHer- NCT05064709 PI: Douglas Ensley, MD
Prospective, multi-center, randomized, quadruple-blind, sham-controlled, two-part embedded trial of the safety and efficacy of CCM therapy delivered via the OPTIMIZER Smart Mini System in subjects with heart failure and an LVEF ≥40% and ≤70%.
Study Details | NCT05064709 | Assessment of CCM in HF With Higher Ejection Fraction | ClinicalTrials.gov
TEAM-HF- NCT06526195 PI: Douglas Ensley, MD
Randomized Arm is a prospective, randomized, open-label study of the HeartMate 3 (HM3) left ventricular assist system (LVAS) versus continued GDMT in non-inotrope dependent HF patients. The objectives of the Randomized Arm are 1) To establish an objective disease-state criteria to trigger referral for a HM3 LVAS and 2) Demonstrate improvement in survival when non-inotrope dependent advanced HF patients are treated with the HM3 LVAS compared to being managed on medical therapy alone.
The TEAM-HF Single Arm Registry is a prospective, single-arm, open-label study of non-inotrope dependent HF patients who do not meet a mean PAP threshold after GDMT optimization. The objective of the Single Arm Registry is to characterize the progression of patients with non-inotrope dependent HF without elevated PAP.
Study Details | NCT06526195 | Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure | ClinicalTrials.gov
OASIS-AMICS- NCT06964685 PI: Aly El Banayosy, MD
This observational study aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella CP during percutaneous coronary intervention (PCI) and who are managed with Impella best practices while receiving guideline-directed standard of care.
Study Details | NCT06964685 | Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock | ClinicalTrials.gov
LAAOS-4- NCT05963698 PI: Tom Hu, DO
Prospective, Multicenter, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
Study Details | NCT05963698 | The Fourth Left Atrial Appendage Occlusion Study | ClinicalTrials.gov
RECOVER-HF- NCT06552637 PI: Douglas Ensley, MD, & Robert Goodwin, DO
Prospective, randomized, doubled-blinded study of Synchronized Diaphragmatic Stimulation (SDS) delivered in an imperceptible manner in subjects with heart failure defined as New York Heart Association (NYHA) functional class II/III, left-ventricular ejection fraction (LVEF) <=40%, and QRS duration <=130ms despite receiving the appropriate heart failure guideline directed medical therapy (GDMT).
Study Details | NCT06552637 | Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure | ClinicalTrials.gov
NORM-HF- NCT07574593 PI: Douglas Ensley, MD
Prospective, International, multi-center, 1:1 randomization, open-label blinded endpoint study designed to demonstrate that use of the FIRE1 NORM™ System in the management of New York Heart Association Class II/III HF patients is superior for reducing the combined endpoint of worsening HF events and cardiovascular mortality compared to standard of care treatment.
Study Details | NCT07574593 | NORM-HF Pivotal Study | ClinicalTrials.gov
BENEFIT-HF- NCT07232030 PI: Douglas Ensley, MD
Demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF < 50% and NT-proBNP < 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices).
Study Details | NCT07232030 | Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure | ClinicalTrials.gov
CLOSED STUDIES
RADIANCE CAP- NCT06369298 PI: Sahil Agrawal, MD
Non-randomized, 2-cohort study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System and to allow for the on-going collection of safety and effectiveness data in two populations of hypertensive subjects. Prior to procedure subjects will be hypertensive despite the prescription of antihypertensive medications.
Study Details | NCT06369298 | Study of JK07 in Patients With Chronic Heart Failure | ClinicalTrials.gov
RENEU-PH- NCT07221513 PI: Douglas Ensley, MD
Phase 2a, open-label, multiple-dose study to assess the safety, tolerability, and efficacy of JK07 in participants 18 to 85 years of age with diagnosed HF and cpcPH.
Study Details | NCT07221513 | Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension | ClinicalTrials.gov
