NCT06125925Recruiting
Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)
Catheter Ablation in Atrial Fibrillation Patients With Heart Failure With Preserved Ejection Fraction: an International, Prospective, Multi-center, Randomized Controlled Study (STABLE-SR IV Trial)
Source: ClinicalTrials.gov · Last updated 11 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To investigate whether RFCA is superior to AADs in AF patients with HFpEF on the basis of optimized anti-heart-failure drug therapy regarding their longterm clinical outcomes.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 436 (estimated)
- First submitted
- 13 Oct 2023
- Start date
- 6 Nov 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT06125925
What you commit to
- Study type: Interventional
- Planned participants: 436
- From 6 Nov 2023 to the primary completion date, Nov 2026
- 1 site 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.
Prior treatment
- Prior atrial fibrillation ablation
- Previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease
- Any contraindication for radiofrequency catheter ablation, antiarrhythmic drugs or anticoagulation
- Acute coronary syndrome, cardiac surgery, angioplasty or cerebrovascular accident within 12 weeks before enrollment
Other illness
- A life expectancy below 2 years due to any non-cardiovascular condition
- Heart failure due to any of the following: known genetic hypertrophic cardiomyopathy, infiltrative cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease
- Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
Other
- Reversible atrial fibrillation, such as hyperthyroidism or hypokalemia-related atrial fibrillation
- Left atrial size≥ 55 mm
- Severe hepatic and renal dysfunction
- Body mass index\> 50 kg/m2
- Female in period of pregnancy or breast-feeding
- Involved in other studies
- The inclusion and exclusion criteria would be reassessed after run-in period and the cut-off of NT-proBNP would be set as \>125 pg/ml under sinus rhythm or \>365 pg/ml under AF/atrial flutter (AFL).
Who the study is looking for
- Symptomatic paroxysmal or persistent atrial fibrillation
- CHADS2-VASc score≥ 2
- Conform to the diagnosis of HFpEF
- NYHA II-IV level;
- Left ventricular ejection fraction (LVEF)≥ 50%;
- NT-proBNP≥ 300 pg/mL under sinus rhythm or NT-proBNP≥ 600 pg/mL under atrial fibrillation or flutter;
- Evidence of left ventricular diastolic dysfunction/raised left ventricular filling pressure on echocardiogram.
- Sign informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.