Status:
NOT_YET_RECRUITING
Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure
Lead Sponsor:
VisCardia Inc.
Collaborating Sponsors:
Clinical Accelerator
Duke Clinical Research Institute
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
Symptomatic Diaphragmatic Stimulation (SDS) is a novel extra-cardiac device for patients who have symptomatic heart failure. Elevated intracardiac pressures are the hallmark of heart failure (HF) and ...
Eligibility Criteria
Inclusion
- NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT)
- QRS duration ≤ 130 ms
- EF≤ 40%
Exclusion
- 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
- Diabetic neuropathy
- Existing diaphragmatic stimulation for respiration assist
- Present LVAD, Baroreflex Activation Therapy, Cardiac Contractility Modulation or interatrial shunt devices; temporary mechanical cardiac assist devices (current or within the previous 3 months); or CRT that is indicated or implanted and functional
- Contraindications to laparoscopic access to the diaphragm, as determined by the implanting physician
- Known intra-abdominal pathology which could increase the risk of laparoscopic access to the diaphragm.
- Previous open laparotomy within 1 year
- Previous thoracic or abdominal organ transplant
- Drug induced immuno-suppression
- Body mass index \> 40
- Enrollment in a concurrent investigation / clinical study
- Having a life expectancy of \<1 year due to any condition
- Pregnant or planning a pregnancy during the study period
- Known allergies to implantable device materials
- History of systemic infection requiring the use of intravenous antibiotics within the previous 3 months
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06552637
Start Date
October 15 2025
End Date
December 1 2027
Last Update
September 4 2025
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