NCT07598760Not yet recruiting
Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction
Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- 30 May 2026
- Primary completion date
- 30 May 2028
- Lead sponsor
- BackBeat Medical Inc
- Diseases
- Heart failure, High blood pressure
- NCT number
- NCT07598760
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 30 May 2026 to the primary completion date, 30 May 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Permanent or persistent atrial fibrillation
- Pregnant or breastfeeding individuals
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tbilisi Heart and Vascular Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Georgian Medical Research Clinic Healthycore Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.