Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure

Recruiting now · Not applicable

Conditions studied: Heart Failure With Reduced Ejection Fraction

In brief

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.

Key facts

Study ID

NCT06552637

Run by

VisCardia Inc.

People needed

270

Starts

2026-07-08

Expected to finish

2029-12-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT)
• QRS duration ≤ 130 ms
• EF≤ 40%

You may not qualify if…

• 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
• Valvular disease requiring intervention within the next 12 months or presence of significant valve disease as determined by the site cardiologist as:
• Greater than mild mitral valve stenosis
• Greater than moderate mitral valve regurgitation
• Greater than mild tricuspid valve stenosis
• Greater than moderate-severe tricuspid valve regurgitation
• Greater than moderate aortic stenosis
• Greater than moderate aortic regurgitation
• Greater than mild-moderate pulmonic stenosis
• Greater than moderate pulmonic regurgitation
• Severe primary pulmonary disease, including pulmonary arterial hypertension. PAP sys >70 mmHg at rest
• Severe COPD, other respiratory or lung diseases where FEV < 50%
• Presence of more than small pleural effusion or history of pleural drainage within the previous 6 months
• Known history of diaphragmatic paralysis or suspicion confirmed by unilateral or bilateral elevation of the diaphragm on chest x-ray
• Pericardial disease

Where it is running

• Saint Francis Hospital — Tulsa, Oklahoma, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia (enrolling)

Full record on ClinicalTrials.gov

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