Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)
Recruiting now · Not applicable
Conditions studied: Atrial Fibrillation, HFpEF - Heart Failure With Preserved Ejection Fraction
In brief
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.
Key facts
- Study ID
- NCT06125925
- Run by
- The First Affiliated Hospital with Nanjing Medical University
- People needed
- 436
- Starts
- 2023-11-06
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2023-12-11
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- A life expectancy below 2 years due to any non-cardiovascular condition
- Reversible atrial fibrillation, such as hyperthyroidism or hypokalemia-related atrial fibrillation
- Prior atrial fibrillation ablation
- Left atrial size≥ 55 mm
- 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
- 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
- Severe hepatic and renal dysfunction
- Body mass index> 50 kg/m2
- Female in period of pregnancy or breast-feeding
- Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
- 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).
Where it is running
- the First Affiliated Hospital of Nanjing Medical University — Nanjing, China (enrolling)
Full record on ClinicalTrials.gov
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