AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Synchronized Diaphragmatic Stimulation in Symptomatic Heart Failure

RecruitingNAAges 18 Years - anyAllVisCardia Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT) for 3 months * EFโ‰ค 40% * At the time of consent, willing and able to comply with protocol requirements, including attending all required visits * Willing to participate in the study and able to sign an informed consent form * โ‰ฅ18 years of age at the time of consent 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, AF (episodes \> 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: 1. Greater than mild mitral valve stenosis 2. Greater than moderate mitral valve regurgitation 3. Greater than mild tricuspid valve stenosis 4. Greater than moderate-severe tricuspid valve regurgitation 5. Greater than moderate aortic stenosis 6. Greater than moderate aortic regurgitation 7. Greater than mild-moderate pulmonic stenosis 8. 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 FEV1 \< 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 * Non-cardiac condition substantially impairing ambulation of 6-minute hall walk test interpretation * 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) * 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 * Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT * Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to AHA/ACC/ESC guidelines for the treatment of congestive heart failure
๐Ÿ’Š

What it tests

  • Synchronized Diaphragmatic Stimulation
๐Ÿ“

Where

5 sites
Ascension St. Vincent Hospital
Indianapolis, United States
Saint Francis Hospital
Tulsa, United States
University of Pennsylvania
Philadelphia, United States
Baylor College of Medicine
Houston, United States
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy