Actively Recruiting
Catheter Ablation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Persistent Atrial Fibrillation and Heart Failure
Led by University Hospital, Geneva · Updated on 2024-12-06
220
Participants Needed
18
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Geneva
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two treatment strategies for patients aged 60 and older with persistent atrial fibrillation and heart failure who are eligible for atrial fibrillation ablation. The study aims to evaluate whether conduction system pacing combined with atrioventricular nodal ablation (CSP+AVNA) is better or as effective as atrial fibrillation ablation by pulmonary vein isolation (PVI) in reducing mortality and hospitalizations. This prospective, randomized, open-label trial is conducted in multiple centers across Europe and plans to enroll 220 participants over four years. Participants will be randomly assigned to one of two groups. One group will undergo catheter ablation of atrial fibrillation, including pulmonary vein isolation using techniques chosen by the investigator. The other group will receive conduction system pacing, either His bundle pacing or left bundle branch area pacing, combined with catheter ablation of the atrioventricular node. Both interventions are conducted as procedures with specialized devices and catheter techniques. During the study, participants will be monitored for up to four years with evaluations including quality of life assessments, heart function measurements such as left ventricular ejection fraction, and tracking of complications and heart failure class. Researchers will assess mortality, cardiovascular and heart failure hospitalizations, and cost-effectiveness of the treatments. The study involves regular follow-up visits to gather clinical data and monitor health status.
CONDITIONS
Brief Title
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persistent atrial fibrillation with symptomatic heart failure despite medical therapy, suitable for atrial fibrillation ablation, with at most one previous pulmonary vein isolation procedure
- At least one prior hospital admission or emergency room/heart failure clinic visit for heart failure in the past 2 years with elevated NT-pro-BNP (>1000 pg/ml) or BNP (>250 pg/ml) levels
- Previous or current treatment with rate or rhythm control medications
- Age greater than 60 years
You will not qualify if you...
- New York Heart Association (NYHA) Class IV heart failure with systolic blood pressure ≤ 80 mmHg despite optimized therapy
- Life expectancy less than 2 years
- Need for major surgical intervention
- Myocardial infarction, stroke, or percutaneous coronary intervention within the previous 3 months
- Previously implanted or planned implantation of cardiac resynchronization therapy device or pacemaker (implantable cardioverter defibrillator without pacing indication is allowed)
- Participation in another controlled clinical trial
- Inability to sign an informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants undergo catheter ablation procedures: either atrial fibrillation ablation with pulmonary vein isolation or conduction system pacing combined with atrioventricular nodal ablation.
Initial procedure visit plus follow-up visits as needed for device management and procedural recovery
Duration - Up to 4 years
Participants are monitored for clinical outcomes including quality of life, heart function, complications, and hospitalizations related to atrial fibrillation and heart failure.
Regular follow-up visits over 4 years
Trial Site Locations
Total: 18 locations
1
St Elisabeth sister's Hospital
Graz, Austria
Not Yet Recruiting
2
Antwerp University Hospital
Antwerp, Belgium
Not Yet Recruiting
3
Acibadem City Clinic Tokuda University Hospital
Sofia, Bulgaria
Not Yet Recruiting
4
University Hospital, Kralovske Vinohrady
Prague, Czechia
Not Yet Recruiting
5
Heart and Lung Center, University of Helsinki
Helsinki, Finland
Actively Recruiting
6
Hôpital Charles Nicolle
Rouen, France
Not Yet Recruiting
7
Herzzentrum Leipzig
Leipzig, Germany
Not Yet Recruiting
8
Semmelweis University
Budapest, Hungary
Not Yet Recruiting
9
Bologna University Hospital
Bologna, Italy
Not Yet Recruiting
10
University Hospital Maastricht
Maastricht, Netherlands
Not Yet Recruiting
11
Jagiellonian University
Krakow, Poland
Not Yet Recruiting
12
Hospital Universitario La Paz
Madrid, Spain
Not Yet Recruiting
13
Hospital Universitario y Politecnico La Fe
Madrid, Spain
Not Yet Recruiting
14
University Hospital Geneva
Geneva, Canton of Geneva, Switzerland, 1211
Actively Recruiting
15
University Hospital of Basel
Basel, Switzerland
Actively Recruiting
16
Inselspital
Bern, Switzerland
Actively Recruiting
17
University Hospital of Zurich
Zurich, Switzerland
Actively Recruiting
18
National Heart and Lung Institute, Imperial College London
London, United Kingdom
Not Yet Recruiting
Research Team
H
Haran Burri
N
Nikola Kozhuharov
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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