Comparing two treatments for heart failure patients with atrial fibrillation

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 aims to evaluate the effectiveness of two treatment strategies for patients suffering from persistent atrial fibrillation and heart failure. Participants will be randomly assigned to either undergo atrial fibrillation ablation or receive a pacemaker with conduction system pacing followed by atrioventricular node ablation. The study will compare the impact of these treatments on total mortality, cardiovascular hospitalizations, and heart failure hospitalizations over a duration of four years across approximately 30 centers in Europe.

Why it matters

Who can join: the full rules

Inclusion Criteria:

(i) Persistent AF with symptomatic HF despite medical therapy, considered to be suitable for AF ablation, with at most one previous PVI procedure.

(ii) At least one prior hospital admission, or emergency room / HF clinic visit for HF in the past 2 years, with NT-pro-BNP \> 1000 pg/ml or BNP \> 250 pg/ml measured at any timepoint during this interval.

(iii) Previous or current rate or rhythm control drug therapy. (iv) Age \> 60 years

Exclusion Criteria:

(i) NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy.

(ii) Life expectancy \< 2 years. (iii) Need for major surgical intervention. (iv) Myocardial infarction, stroke or PCI within the previous 3 months. (v) Previously implanted or planned implantation of CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable.

(vi) Participation in another controlled trial. (vii) Inability to sign and informed consent form.

Where it's running

• Heart and Lung Center, University of Helsinki
  Helsinki, Finland Recruiting
• University Hospital Geneva
  Geneva, Canton of Geneva, Switzerland Recruiting
• University Hospital of Basel
  Basel, Switzerland Recruiting
• Inselspital
  Bern, Switzerland Recruiting
• University Hospital of Zurich
  Zurich, Switzerland Recruiting
• St Elisabeth sister's Hospital
  Graz, Austria Not yet recruiting

Study contacts

• Study coordinator: Haran Burri
• Email: haran.burri@hcuge.ch
• Phone: +41794616217

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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.