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Catheter Ablation for Atrial Fibrillation in Adults With Preserved-Ejection Heart Failure

Compares catheter ablation with drug therapy in adults with atrial fibrillation and heart failure.

Plain-language title generated from the registry record
Registry title: Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)

Key facts

Where
Nanjing, ChinaSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with symptomatic atrial fibrillation and heart failure with preserved ejection fraction (HFpEF). It compares catheter ablation with antiarrhythmic drugs.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
Symptomatic paroxysmal or persistent atrial fibrillation, CHADS2-VASc score of 2 or more, and HFpEF: NYHA class II-IV, LVEF 50% or more, raised NT-proBNP, and signs of diastolic dysfunction on echocardiogram.
Earlier treatment
No prior atrial fibrillation ablation. No cardiac transplant. No acute coronary syndrome, cardiac surgery, angioplasty or stroke within 12 weeks before enrollment.
Biomarker or test result
NT-proBNP of 300 pg/mL or more in sinus rhythm, or 600 pg/mL or more in atrial fibrillation or flutter.

Main reasons for not taking part

  • Left atrial size of 55 mm or more
  • Reversible atrial fibrillation, such as from hyperthyroidism or low potassium
  • Heart failure from other heart diseases, such as hypertrophic or infiltrative cardiomyopathy or uncorrected valve disease
  • Severe liver or kidney dysfunction
  • Pregnant or breast-feeding women

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Source: NCT06125925, who can take part

Where in China

  • The First Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
The First Affiliated Hospital with Nanjing Medical University
Trial code
NCT06125925
Record updated
11 December 2023
Original description
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.Read full original descriptionShow less

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)

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.

Inclusion: 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.

Exclusion: 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; 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; 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).

ClinicalTrials.gov NCT06125925