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.
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
NYHA class IV heart failure
Permanent or persistent atrial fibrillation
Recent acute decompensated heart failure
Significant valvular heart disease requiring intervention
Single group
Moderato Plus device with Cardiac Neuromodulation Therapy
DeviceModerato Plus System with CNT
Change in Cardiac Output During Supine Exercise
Cardiac output measured during supine rest and graded supine bicycle exercise using thermodilution techniques, with CNT activated and deactivated, at baseline and at 6 months. Results will be summarized as the change in cardiac output during exercise between baseline and follow-up.
Change in 24-Hour Ambulatory Systolic Blood Pressure
Change in average 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM), comparing baseline and the 3-month visit.
Change in Daytime and Nighttime Ambulatory Systolic Blood Pressure
Change in average daytime and nighttime systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM), comparing baseline and the 3-month visit.
Change in Office Blood Pressure Measurements
Change in office-based systolic and diastolic blood pressure measurements at each study visit compared to baseline.
Change in NYHA Functional Class
Change in New York Heart Association (NYHA) functional classification assessed at Visits 4 (3 months) and 6 (12 months) compared with baseline.
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