Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction
Starting soon · Not applicable
Conditions studied: Hypertension (HTN), Heart Failure With Preserved Ejection Fraction (HFpEF, Hypertension, Systolic
In brief
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.
Key facts
- Study ID
- NCT07598760
- Run by
- BackBeat Medical Inc
- People needed
- 20
- Starts
- 2026-05-30
- Expected to finish
- 2028-11-30
- Last updated by the study team
- 2026-05-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- NYHA class IV heart failure
- Permanent or persistent atrial fibrillation
- 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
- Pregnant or breastfeeding individuals
Where it is running
- Georgian Medical Research Clinic Healthycore — Tbilisi, Georgia
- Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia
Full record on ClinicalTrials.gov
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