Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure (ABACUS)

December 3, 2024 updated by: Haran Burri, MD, University Hospital, Geneva

Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim To compare clinical outcome with a strategy of conduction system pacing and atrioventricular nodal ablation (CSP+AVNA), versus atrial fibrillation (AF) ablation by pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) and heart failure (HF), to guide future management of these patients.

Hypotheses

  1. CSP+AVNA is superior to AF ablation in patients with persistent AF and HF for reducing mortality and cardiovascular hospitalization.
  2. CSP+AVNA is non-inferior to AF ablation in patients with persistent AF for reducing mortality and heart failure hospitalization.

Design Investigator-initiated, prospective randomized, controlled, open-label, multicentre study conducted in ~ 30 centres from 14 countries in Europe with expertise in CSP and AF ablation.

Sample size 220 patients

Study duration 4 years

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Atrial fibrillation ablation
Catheter ablation of atrial fibrillation using technique at the investigator's discretion but including pulmonary vein isolation as an endpoint.
Procedure: Atrial fibrillation ablation
Catheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary)
Active Comparator: Conduction system pacing + atrioventricular nodal ablation
Conduction system pacing (either His bundle pacing or left bundle branch area pacing) with catheter ablation of the atrioventricular node.
Device: Conduction system pacing
Conduction system pacing (either His bundle pacing or left bundle branch area pacing)
Procedure: Atrioventricular nodal ablation
Catheter ablation of the atrioventricular node

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superiority endpoint
Time Frame: 1-4 years
Incidence of mortality and cardiovascular hospitalization in each arm
1-4 years
Non-inferiority endpoint
Time Frame: 1-4 years
Incidence of mortality and heart failure hospitalization in each arm
1-4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minnesota Living with Heart Failure quality of life measure
Time Frame: 1 year
The questionnaire is comprised of 21 questions around physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. The patient marks a 0-5 scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is scored by summation of all 21 responses (the higher the score, the worse the quality of life).
1 year
Left ventricular ejection fraction
Time Frame: 1 year
Measurement using echocardiography
1 year
Complications
Time Frame: 1-4 years
Peri-procedural and long-term
1-4 years
NYHA class
Time Frame: 1-4 years
New York Heart Association classification of heart failure symptoms
1-4 years
Cost-Effectiveness Analysis
Time Frame: 1-4 years
Evaluation of clinical outcomes and associated costs between between the study arms. This evaluation will be conducted from a societal perspective, capturing both the direct medical costs and the broader societal impacts of the interventions.
1-4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Swiss National Science Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNF_32003B_220116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data repository

IPD Sharing Time Frame

After study closure

IPD Sharing Access Criteria

Request to study P.I.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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