Comparing two treatments for heart failure patients with atrial fibrillation
Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure
This study is testing two different treatments for heart failure patients with atrial fibrillation to see which one helps them live longer and stay out of the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 18 sites (Graz and 17 other locations) |
| Trial ID | NCT06207383 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 60 years old with persistent atrial fibrillation and symptomatic heart failure despite medical therapy.
Not a fit: Patients with advanced heart failure (NYHA Class IV) or those with a life expectancy of less than two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for heart failure patients with persistent atrial fibrillation, potentially improving survival and reducing hospitalizations.
How similar studies have performed: Other studies have explored similar treatment strategies, but this specific comparison of conduction system pacing with atrioventricular nodal ablation versus atrial fibrillation ablation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Graz and 17 other locations
- St Elisabeth sister's Hospital — Graz, Austria (Not_yet_recruiting)
- Antwerp University Hospital — Antwerp, Belgium (Not_yet_recruiting)
- Acibadem City Clinic Tokuda University Hospital — Sofia, Bulgaria (Not_yet_recruiting)
- University Hospital, Kralovske Vinohrady — Prague, Czechia (Not_yet_recruiting)
- Heart and Lung Center, University of Helsinki — Helsinki, Finland (Recruiting)
- Hôpital Charles Nicolle — Rouen, France (Not_yet_recruiting)
- Herzzentrum Leipzig — Leipzig, Germany (Not_yet_recruiting)
- Semmelweis University — Budapest, Hungary (Not_yet_recruiting)
- Bologna University Hospital — Bologna, Italy (Not_yet_recruiting)
- University Hospital Maastricht — Maastricht, Netherlands (Not_yet_recruiting)
- Jagiellonian University — Krakow, Poland (Not_yet_recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Not_yet_recruiting)
- Hospital Universitario y Politecnico La Fe — Madrid, Spain (Not_yet_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)
- National Heart and Lung Institute, Imperial College London — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Haran Burri
- Email: haran.burri@hcuge.ch
- Phone: +41794616217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.