Synchronized diaphragmatic stimulation for symptomatic heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Synchronized diaphragmatic stimulation (SDS) uses an implanted VisONE System to rhythmically modulate intrathoracic pressure in time with the cardiac cycle to potentially improve cardiac filling and performance. All enrolled participants receive the VisONE implant, and two weeks after implantation they are randomized 1:1 in a double-blind fashion to active SDS or inactive (sham) programming while continuing guideline-directed medical therapy. Outcomes include safety and measures of symptoms, exercise capacity, biomarkers, and cardiac function with scheduled follow-up visits, including assessment at six months. The trial targets patients with NYHA class II–III heart failure, LVEF ≤40%, and QRS duration ≤130 ms who have not improved sufficiently on medical therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* NYHA classes II/III on optimal Guideline Directed Medical Therapy (GDMT) for 3 months
* EF≤ 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
* ≥18 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

Where it's running

• Ascension St. Vincent Hospital
  Indianapolis, Indiana, United States Recruiting
• Saint Francis Hospital
  Tulsa, Oklahoma, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting
• Tbilisi Heart and Vascular Clinic
  Tbilisi, Georgia Recruiting

Study contacts

• Principal investigator: Lee R Goldberg, MD — University of Pennsylvania
• Study coordinator: Calvin Flowers
• Email: flowersc@viscardia.com
• Phone: (503) 431-3823

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.