Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT06207383

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

Led by University Hospital, Geneva · Updated on 2024-12-06

220

Participants Needed

18

Research Sites

217 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Geneva

Lead Sponsor

S

Swiss National Science Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Persistent atrial fibrillation with symptomatic heart failure despite medical therapy, suitable for atrial fibrillation ablation, with at most one previous pulmonary vein isolation procedure
  • At least one hospital admission or emergency room/heart failure clinic visit for heart failure in the past 2 years with NT-pro-BNP > 1000 pg/ml or BNP > 250 pg/ml measured during this period
  • Previous or current treatment with rate or rhythm control drugs
  • Age over 60 years
Not Eligible

You will not qualify if you...

  • New York Heart Association (NYHA) Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy
  • Life expectancy less than 2 years
  • Need for major surgical intervention
  • Myocardial infarction, stroke, or percutaneous coronary intervention within the previous 3 months
  • Previously implanted or planned implantation of cardiac resynchronization therapy device or pacemaker (implantable cardioverter defibrillator implantation without pacing indication is allowed)
  • Participation in another controlled trial
  • Inability to sign an informed consent form

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

St Elisabeth sister's Hospital

Graz, Austria

Not Yet Recruiting

2

Antwerp University Hospital

Antwerp, Belgium

Not Yet Recruiting

3

Acibadem City Clinic Tokuda University Hospital

Sofia, Bulgaria

Not Yet Recruiting

4

University Hospital, Kralovske Vinohrady

Prague, Czechia

Not Yet Recruiting

5

Heart and Lung Center, University of Helsinki

Helsinki, Finland

Actively Recruiting

6

Hôpital Charles Nicolle

Rouen, France

Not Yet Recruiting

7

Herzzentrum Leipzig

Leipzig, Germany

Not Yet Recruiting

8

Semmelweis University

Budapest, Hungary

Not Yet Recruiting

9

Bologna University Hospital

Bologna, Italy

Not Yet Recruiting

10

University Hospital Maastricht

Maastricht, Netherlands

Not Yet Recruiting

11

Jagiellonian University

Krakow, Poland

Not Yet Recruiting

12

Hospital Universitario La Paz

Madrid, Spain

Not Yet Recruiting

13

Hospital Universitario y Politecnico La Fe

Madrid, Spain

Not Yet Recruiting

14

University Hospital Geneva

Geneva, Canton of Geneva, Switzerland, 1211

Actively Recruiting

15

University Hospital of Basel

Basel, Switzerland

Actively Recruiting

16

Inselspital

Bern, Switzerland

Actively Recruiting

17

University Hospital of Zurich

Zurich, Switzerland

Actively Recruiting

18

National Heart and Lung Institute, Imperial College London

London, United Kingdom

Not Yet Recruiting

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Research Team

H

Haran Burri

CONTACT

N

Nikola Kozhuharov

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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