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

Plain Language Summary

Simplified for easier understanding

This study compares two procedures in people with persistent irregular heart rhythm (atrial fibrillation) and heart failure: one that burns away the source of the irregular rhythm (AF ablation), and one that blocks the signal between the upper and lower heart chambers while implanting a special pacemaker. The goal is to find out which approach better improves heart failure symptoms. **You may be eligible if...** - You are over 60 with persistent atrial fibrillation and heart failure symptoms despite medication - You have been hospitalized or visited an ER for heart failure in the past 2 years - Your blood has shown elevated heart failure markers (BNP or NT-proBNP) - You have already tried rate or rhythm control medications **You may NOT be eligible if...** - Your heart failure is in the most severe stage (NYHA Class IV with very low blood pressure) - You have a life expectancy of less than 2 years - You have already had more than one prior ablation procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

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NCT06207383


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