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Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
BackBeat Medical Inc
10 trials monitored
See all monitored trials
Heart Disease
8,786 trials monitored
See 412 trials at risk
Heart Failure
1,995 trials monitored
See 111 trials at risk
Hypertension
1,925 trials monitored
See 99 trials at risk
This is an open-label pilot study to evaluate the feasibility of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who require dual-chamber pacemaker implantation or replacement. The study will assess blood pressure and heart function at rest and during exercise, with and without CNT, for up to 12 months. Participants will receive the Moderato Plus device and complete scheduled follow-up visits. After study completion, CNT therapy will be discontinued and participants will return to standard medical care.
Trial Details
NCT Number NCT07598760
Lead Sponsor BackBeat Medical Inc
Conditions
(from sponsor)		 Hypertension (HTN), Heart Failure With Preserved Ejection Fraction (HFpEF, Hypertension, Systolic
Related terms Hypertension, Isolated Systolic Hypertension
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov