About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 18 years or older

Clinical indication for dual-chamber pacemaker implantation or replacement

Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction ≥50%

History of hypertension

Disqualifiers

NYHA class IV heart failure

Permanent or persistent atrial fibrillation

Recent acute decompensated heart failure

Significant valvular heart disease requiring intervention

Trial design

Treatments tested in this trial

  • Moderato Plus device with Cardiac Neuromodulation Therapy

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

2
Georgian Medical Research Clinic Healthycore Tbilisi Georgia
Tbilisi Heart and Vascular Clinic Tbilisi Georgia

Sponsors and collaborators

BackBeat Medical Inc

Lead sponsor