RECOVER-HFNCT06552637
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
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Record History
All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗
- Minor Trial sites expanded: 3 → 6 locations
- Notable Eligibility criteria expanded, about 81 words
- Minor Study sites: 4 to 5
- Notable Eligibility criteria expanded, about 7 words
- Study sites: 3 to 4
- Study description revised
- Minor Study sites: 1 to 3
- Start date changed from estimate of Apr 30, 2026 to Jul 8, 2026
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Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
- Primary completion date: Jul 2027 to Jul 2028
- Start date: Oct 15, 2025 to Apr 30, 2026
- Study sites: 0 to 1
- Study completion date: Dec 2027 to Dec 2029
- Notable Start date: Oct 2024 to Oct 15, 2025
- Eligibility criteria expanded, about 149 words
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Secondary (5)
Arms and interventions
* Subjects will be implanted with the VisONE System programmed to deliver SDS (Therapy On) and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines) including those drugs to be determined by the subject's physician * Assigned Interventions: * Device: VisONE System (SDS) * Drug: Medical Management
* Subjects will be implanted with the VisONE System programmed not to deliver SDS (Therapy Off) and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines) including those drugs to be determined by the subject's physician * Assigned Interventions: * Drug: Medical Management
Devices: Synchronized Diaphragmatic Stimulation
Sites
6 sites in 2 countries
United States 4, Georgia 2