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Catheter Ablation in Atrial Fibrillation Patients With HFpEF (STABLE-SR IV Trial)

RECRUITINGN/ASponsored by The First Affiliated Hospital with Nanjing Medical University
Actively Recruiting
PhaseN/A
SponsorThe First Affiliated Hospital with Nanjing Medical University
Started2023-11-06
Est. completion2026-11
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06125925

Summary

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.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

* Symptomatic paroxysmal or persistent atrial fibrillation
* CHADS2-VASc score≥ 2
* Conform to the diagnosis of HFpEF

  1. NYHA II-IV level;
  2. Left ventricular ejection fraction (LVEF)≥ 50%;
  3. NT-proBNP≥ 300 pg/mL under sinus rhythm or NT-proBNP≥ 600 pg/mL under atrial fibrillation or flutter;
  4. Evidence of left ventricular diastolic dysfunction/raised left ventricular filling pressure on echocardiogram.
* Sign informed consent

Exclusion Criteria:

* 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).

Conditions3

Atrial FibrillationHFpEF - Heart Failure With Preserved Ejection FractionHeart Disease

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