Tests whether cardiac neuromodulation therapy is workable in heart failure with high blood pressure
Tests cardiac neuromodulation therapy in adults with heart failure and high blood pressure.
Plain-language title generated from the registry record
Registry title: Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction
Key facts
- Where
- Tbilisi, GeorgiaSee the 2 sites
Where in Georgia
- Georgian Medical Research Clinic HealthycoreTbilisi, GeorgiaNo longer taking part
- Tbilisi Heart and Vascular ClinicTbilisi, GeorgiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BackBeat Medical Inc
- Trial code
- NCT07598760
- Record updated
- 20 May 2026
- Original description
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.Read full original descriptionShow less
Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF
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.
Inclusion: 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 functional class II or III; On stable guideline-directed medical therapy; Able and willing to provide written informed consent.
Exclusion: NYHA class IV heart failure; Recent acute decompensated heart failure; Significant valvular heart disease requiring intervention; Severe comorbid conditions that, in the investigator's judgment, would make study participation unsafe; Permanent or persistent atrial fibrillation; Pregnant or breastfeeding individuals.