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Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction
Sponsor: BackBeat Medical Inc
Summary
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.
Official title: Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-05-30
Completion Date
2028-11-30
Last Updated
2026-05-20
Healthy Volunteers
No
Conditions
Interventions
Moderato Plus device with Cardiac Neuromodulation Therapy
Moderato Plus System with CNT
Locations (2)
Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia