🏛️ Verified NIH Record • Updated 2026-07-29
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure (NCT06552637)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: VisCardia Inc.
🩺 Plain-English Summary (8th-Grade Level)
RECOVER HF is a clinical study designed to evaluate the safety and efficacy of Synchronized Diaphragmatic Stimulation delivered using the VisONE System in the treatment of patients with heart failure.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (40 items).
Location: Saint Francis Hospital — Tulsa, Oklahoma
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Baseline 6 minute walk test \> 500 meters or \< 200 meters
- NT-proBNP\< 250 if on loop diuretics, or NT-proBNP \< 500 if not on loop diuretics
- Supine resting heart rate \> 140 bpm
- Systolic blood pressure \< 80 mmHg or \> 170 mmHg
- Serum creatinine \> 2.5 mg/dL
- Serum hepatic function 3x ULN
- Any of the following within the previous 3 months: unstable angina, AMI, CABG, PTCA, CVA/TIA, persistent AF (\> 24 hours), symptomatic NSVT or DCCV
- Any inotropic drug treatment within the previous 3 months
- Bradycardia (heart rate \< 50 beats/min), atrial arrhythmias with rates \> 100 beats/min, sustained ventricular tachycardia or frequent ventricular ectopy \>10% present during screening
- Significant uncontrolled symptomatic bradyarrhythmia, atrial fibrillation, unstable ventricular arrhythmias or frequent ventricular ectopy \> 10% documented within the previous 3 months
- Reversible non-ischemic cardiomyopathy
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- Saint Francis Hospital — Tulsa, Oklahoma
- University of Pennsylvania — Philadelphia, Pennsylvania
- Tbilisi Heart and Vascular Clinic — Tbilisi,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.