RecruitingNot ApplicableNCT06207383

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

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


Sponsor

University Hospital, Geneva

Enrollment

220 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 60 Years

Inclusion Criteria3

  • (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 Criteria3

  • (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.

Interventions

DEVICEConduction system pacing

Conduction system pacing (either His bundle pacing or left bundle branch area pacing)

PROCEDUREAtrioventricular nodal ablation

Catheter ablation of the atrioventricular node

PROCEDUREAtrial fibrillation ablation

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


Locations(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, 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

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NCT06207383


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