Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation With Conduction System Pacing in Heart Failure

Heart Failure Clinical Trial

— ABACUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06207383
• Other study ID #: SNF_32003B_220116
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2028

Study information

• Verified date: January 2024
• Source: University Hospital, Geneva
• Contact: Haran Burri
• Phone: +41794616217
• Email: haran.burri[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Heart Failure

Intervention

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
• Atrial fibrillation ablation
Catheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary)

Locations

Country	Name	City	State
Austria	St Elisabeth sister's Hospital	Graz
Belgium	Antwerp University Hospital	Antwerp
Bulgaria	Acibadem City Clinic Tokuda University Hospital	Sofia
Czechia	University Hospital, Kralovske Vinohrady	Praha
Finland	Heart and Lung Center, University of Helsinki	Helsinki
France	CHU Rennes	Rennes
Germany	Herzzentrum Leipzig	Leipzig
Hungary	Semmelweis University	Budapest
Italy	Ospedali del Tigullio	Lavagna
Netherlands	University Hospital Maastricht	Maastricht
Poland	Jagiellonian University	Kraków
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario y Politecnico La Fe	Madrid
Switzerland	University Hospital of Basel	Basel
Switzerland	Inselspital	Bern
Switzerland	University Hospital Geneva	Geneva	GE
Switzerland	University Hospital of Zurich	Zurich
United Kingdom	National Heart and Lung Institute, Imperial College London	London

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Swiss National Science Foundation

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Czechia,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superiority endpoint	Incidence of mortality and cardiovascular hospitalization in each arm	1-4 years
Primary	Non-inferiority endpoint	Incidence of mortality and heart failure hospitalization in each arm	1-4 years
Secondary	Minnesota Living with Heart Failure quality of life measure	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
Secondary	Left ventricular ejection fraction	Measurement using echocardiography	1 year
Secondary	Complications	Peri-procedural and long-term	1-4 years
Secondary	NYHA class	New York Heart Association classification of heart failure symptoms	1-4 years
Secondary	Cost-Effectiveness Analysis	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