Baroreflex Activation Therapy in Left Ventricular Assist Device Patients Study

Launched by BRIAN HOUSTON · Jan 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called Baroreflex Activation Therapy (BAT) in patients who have received a Left Ventricular Assist Device (LVAD) for congestive heart failure. The trial aims to understand how the BAT device, which helps improve heart function, works over time in these patients. It will be conducted as a double-blind cross-over study, meaning that some participants will receive the treatment while others will not, and then they will switch after a certain period. This helps researchers compare how well the treatment works.

To be eligible for this study, participants must be over 18 years old and have had their LVAD implanted for at least three months, with an existing BAT device already in place. However, individuals with serious heart issues, such as unstable heart failure or certain heart rhythms, will not be able to participate. If you join the study, you can expect regular check-ups and monitoring to assess how the BAT affects your health. This trial is currently recruiting participants, and it includes anyone within the specified age range, regardless of gender.

Gender

ALL

Eligibility 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