Comparing catheter ablation and drug therapy for atrial fibrillation in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether radiofrequency catheter ablation (RFCA) is more effective than antiarrhythmic drugs (AADs) for patients with atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF). The study is a prospective, multi-center, randomized controlled trial that aims to assess long-term clinical outcomes in these patients. Participants will undergo a run-in period of optimized anti-heart-failure therapy before being randomized to receive either RFCA or AADs. The trial will evaluate various clinical parameters, including echocardiograms and blood tests, to determine the efficacy of the interventions.

Why it matters

Who can join: the full rules

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).

Where it's running

• the First Affiliated Hospital of Nanjing Medical University
  Nanjing, China Recruiting

Study contacts

• Study coordinator: Hailei Liu, PhD
• Email: liuhailei@njmu.edu.cn
• Phone: +86-18094226858

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

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• Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.