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

Last updated: December 3, 2024
Sponsor: University Hospital, Geneva
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Dysrhythmia

Treatment

Atrial fibrillation ablation

Conduction system pacing

Atrioventricular nodal ablation

Clinical Study ID

NCT06207383
SNF_32003B_220116
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 220
Treatment Group(s): 3
Primary Treatment: Atrial fibrillation ablation
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
December 31, 2028

Study 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

Connect with a study center

  • St Elisabeth sister's Hospital

    Graz,
    Austria

    Site Not Available

  • Antwerp University Hospital

    Antwerp,
    Belgium

    Site Not Available

  • Acibadem City Clinic Tokuda University Hospital

    Sofia,
    Bulgaria

    Site Not Available

  • University Hospital, Kralovske Vinohrady

    Praha,
    Czech Republic

    Site Not Available

  • University Hospital, Kralovske Vinohrady

    Praha,
    Czechia

    Site Not Available

  • Heart and Lung Center, University of Helsinki

    Helsinki,
    Finland

    Active - Recruiting

  • CHU Rennes

    Rennes,
    France

    Site Not Available

  • Hôpital Charles Nicolle

    Rouen,
    France

    Site Not Available

  • Herzzentrum Leipzig

    Leipzig,
    Germany

    Site Not Available

  • Semmelweis University

    Budapest,
    Hungary

    Site Not Available

  • Bologna University Hospital

    Bologna,
    Italy

    Site Not Available

  • Ospedali del Tigullio

    Lavagna,
    Italy

    Site Not Available

  • University Hospital Maastricht

    Maastricht,
    Netherlands

    Site Not Available

  • Jagiellonian University

    Kraków,
    Poland

    Site Not Available

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe

    Madrid,
    Spain

    Site Not Available

  • University Hospital Geneva

    Geneva, GE 1211
    Switzerland

    Active - Recruiting

  • University Hospital of Basel

    Basel,
    Switzerland

    Active - Recruiting

  • Inselspital

    Bern,
    Switzerland

    Active - Recruiting

  • University Hospital of Zurich

    Zurich,
    Switzerland

    Active - Recruiting

  • National Heart and Lung Institute, Imperial College London

    London,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.