Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
ABACUS
Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure
1 other identifier
interventional
220
14 countries
18
Brief Summary
The goal of this clinical trial is to evaluate two treatment strategies in patients with chronic atrial fibrillation and heart failure, who are eligible for atrial fibrillation ablation. Patients will be randomized to either atrial fibrillation ablation or to implantation of a pacemaker with conduction system pacing followed by atrioventricular node ablation. The effect of treatment allocation on total mortality, cardiovascular hospitalization and heart failure hospitalization will be compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
December 6, 2024
December 1, 2024
3.7 years
December 17, 2023
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Superiority endpoint
Incidence of mortality and cardiovascular hospitalization in each arm
1-4 years
Non-inferiority endpoint
Incidence of mortality and heart failure hospitalization in each arm
1-4 years
Secondary Outcomes (5)
Minnesota Living with Heart Failure quality of life measure
1 year
Left ventricular ejection fraction
1 year
Complications
1-4 years
NYHA class
1-4 years
Cost-Effectiveness Analysis
1-4 years
Study Arms (2)
Atrial fibrillation ablation
OTHERCatheter ablation of atrial fibrillation using technique at the investigator's discretion but including pulmonary vein isolation as an endpoint.
Conduction system pacing + atrioventricular nodal ablation
ACTIVE COMPARATORConduction system pacing (either His bundle pacing or left bundle branch area pacing) with catheter ablation of the atrioventricular node.
Interventions
Conduction system pacing (either His bundle pacing or left bundle branch area pacing)
Catheter ablation of the atrioventricular node
Catheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary)
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Genevalead
- Swiss National Science Foundationcollaborator
Study Sites (18)
St Elisabeth sister's Hospital
Graz, Austria
Antwerp University Hospital
Antwerp, Belgium
Acibadem City Clinic Tokuda University Hospital
Sofia, Bulgaria
University Hospital, Kralovske Vinohrady
Prague, Czechia
Heart and Lung Center, University of Helsinki
Helsinki, Finland
Hôpital Charles Nicolle
Rouen, France
Herzzentrum Leipzig
Leipzig, Germany
Semmelweis University
Budapest, Hungary
Bologna University Hospital
Bologna, Italy
University Hospital Maastricht
Maastricht, Netherlands
Jagiellonian University
Krakow, Poland
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario y Politecnico La Fe
Madrid, Spain
University Hospital Geneva
Geneva, Canton of Geneva, 1211, Switzerland
University Hospital of Basel
Basel, Switzerland
Inselspital
Bern, Switzerland
University Hospital of Zurich
Zurich, Switzerland
National Heart and Lung Institute, Imperial College London
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Investigator and Sponsor Representative
Study Record Dates
First Submitted
December 17, 2023
First Posted
January 17, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
December 6, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After study closure
- Access Criteria
- Request to study P.I.
Data repository