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RECOVER-HF Pilot Study of SDS in Heart Failure

NCT05592392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-09-22

No results posted yet for this study

Summary

The RECOVER HF pilot is a feasibility study for evaluating a randomized, doubled-blinded study design to determine the benefits and risks of chronically delivering Synchronized Diaphragmatic Stimulation (SDS) in Heart Failure patients on GDMT with NYHA II/III, EF\<=40% and QRSd,=130ms.

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DEVICE

Synchronized Diaphragmatic Stimulation

Implantable Pulse Generator system providing cardiac-gaited stimulation of the diaphragm and thereby influence cardiovascular properties relevant in heart failure.

Sponsors & Collaborators

  • Clinical Accelerator

    collaborator INDUSTRY

  • VisCardia Inc.

    lead INDUSTRY

Principal Investigators

  • Tamaz Shaburishvili, MD, PhD · Tbilisi Heart and Vascular Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2024-09-30
Completion
2025-02-28

Countries

  • Georgia
  • Uzbekistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05592392 on ClinicalTrials.gov