Baroreflex Activation Therapy for patients with Left Ventricular Assist Devices
Baroreflex Activation Therapy in Left Ventricular Assist Device Patients Study (BAT-VAD Study)
NA · Medical University of South Carolina · NCT06195046
This study is testing if Baroreflex Activation Therapy can help improve heart recovery and overall health in patients who have received a Left Ventricular Assist Device.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06195046 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Baroreflex Activation Therapy (BAT) in patients who have received a Left Ventricular Assist Device (LVAD) and are at least three months post-implant. It employs a double-blind cross-over design to assess the impact of BAT on these patients, who often experience persistent neurohormonal activation despite LVAD support. The goal is to explore whether BAT can enhance myocardial recovery and improve overall patient outcomes. This research is crucial as it addresses the challenges faced by LVAD patients, particularly the limited recovery rates and ongoing heart failure symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years who have had an LVAD implanted for more than three months and already have a BAT device.
Not a fit: Patients experiencing cardiogenic shock, respiratory failure, or significant arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve heart function and quality of life for LVAD patients.
How similar studies have performed: While the approach of using BAT in LVAD patients is innovative, similar studies have shown promise in addressing neurohormonal activation in heart failure patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * LVAD patient \> 3 months post implant * Existing BAT device Exclusion Criteria: * Presence of cardiogenic shock, respiratory failure, hypotension or unstable heart failure * Bradycardia (resting HR \<60 beats/minute) * Presence of suspected pump thrombosis at the time of enrollment * Presence of any significant ventricular arrhythmias at the time of enrollment
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congestive Heart Failure, Ventricular Assist Device, Baroreflex activation therapy