RESPONDER-HF- NCT05425459 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 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.
INTEGRA-D- NCT05855135 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).
AIM-HIGHer- NCT05064709 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%.
TEAM-HF- NCT06526195 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.
OASIS-AMICS- Observational Study
LAAOS-4- NCT05963698 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 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).
NORM-HF- NCT05763407 Early Feasibility Study of the NORM™ System in Heart Failure Patients
BENEFIT-HF- NCT07232030 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).