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
Locations
2Sponsors and collaborators
BackBeat Medical Inc
Lead sponsor