BackBeat Medical Cardiac Neuromodulation Therapy in Patients With Heart Failure: An Acute Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- BackBeat Medical Inc
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in Arterial Elastance
Study Overview
Brief Summary
This investigation will evaluate the ability of the Moderato® System to safely and effectively deliver CNT, to reduce sympathetic activity in heart failure patients
Detailed Description
This will be a single center, non-randomized observational study. The Moderato® System is approved for marketing in Europe (has a CE mark) for the treatment of high blood pressure in patients requiring standard cardiac pacing. The therapy delivered by the Moderato® System is referred to as CNT (Cardiac Neuromodulation Therapy). Heart failure patients is a population for which the Moderato® device is currently not indicated.
Subjects requiring an implantable cardiac defibrillator (ICD) implantation or replacement and meeting study inclusion and exclusion criteria will be eligible to participate in the study. The study procedure will take place during the ICD implantation (or replacement).
The whole procedure will be performed according to standard of care for ICD implantations (or replacements) including periprocedural prophylactic antibiotics prophylactic. To reduce the time of wound exposure, the setup of system for invasive measurements will be done before the ICD implant (or replacement) procedure begins.
The groin area will be prepared and draped. After applying local anesthesia, a 7Fr sheath will be inserted into the femoral artery. A small dose of heparin (~5000 units) will be administered intravenously to prevent formation of blood clots. Under fluoroscopic guidance, a standard conductance catheter (CD Leycom CA-71103-PL, CE marked) will be advanced into the left ventricle.
The arterial line will be used to measure arterial pressure. This completes the measuring system setup.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is ≥ 18 years of age
- •Subject has a primary indication and is scheduled for ICD implantation or replacement
- •Subject has heart failure NYHA Class II or III
Exclusion Criteria
- •Subject is to receive a single chamber defibrillator
- •Subject has an ejection fraction of 25% or less
- •Subject's systolic blood pressure is less than 120 mm Hg on the day of implant
- •Subject has decompensated heart failure
- •Subject has significant (>2+) mitral regurgitation, aortic regurgitation or aortic stenosis.
- •Subject has permanent atrial fibrillation
- •Subject has atrial fibrillation on the day of the study.
- •Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
- •Subject has a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke or TIA) at any prior time that has resulted in residual neurologic deficit.
- •Subject has a history of autonomic dysfunction
- •Women who are pregnant or breast-feeding
- •Subject cannot or is unwilling to provide informed consent.
Outcomes
Primary Outcomes
Change in Arterial Elastance
Time Frame: Immediate, derived form ongoing Pressure Volume changes in the Left ventricle
Arterial elastance is reduced when sympathetic activity is reduced, an indication of a relaxed peripheral resistance.
Secondary Outcomes
No secondary outcomes reported