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

NCT ID: NCT06207383

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Atrial Fibrillation, Persistent Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Atrial fibrillation ablation

Catheter ablation of atrial fibrillation using technique at the investigator's discretion but including pulmonary vein isolation as an endpoint.

Group Type OTHER

Atrial fibrillation ablation

Intervention Type PROCEDURE

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

Conduction system pacing + atrioventricular nodal ablation

Conduction system pacing (either His bundle pacing or left bundle branch area pacing) with catheter ablation of the atrioventricular node.

Group Type ACTIVE_COMPARATOR

Conduction system pacing

Intervention Type DEVICE

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

Atrioventricular nodal ablation

Intervention Type PROCEDURE

Catheter ablation of the atrioventricular node

Interventions

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Conduction system pacing

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

Intervention Type DEVICE

Atrioventricular nodal ablation

Catheter ablation of the atrioventricular node

Intervention Type PROCEDURE

Atrial fibrillation ablation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Haran Burri, MD

Chief Investigator and Sponsor Representative

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St Elisabeth sister's Hospital

Graz, , Austria

Site Status NOT_YET_RECRUITING

Antwerp University Hospital

Antwerp, , Belgium

Site Status NOT_YET_RECRUITING

Acibadem City Clinic Tokuda University Hospital

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

University Hospital, Kralovske Vinohrady

Prague, , Czechia

Site Status NOT_YET_RECRUITING

Heart and Lung Center, University of Helsinki

Helsinki, , Finland

Site Status RECRUITING

Hôpital Charles Nicolle

Rouen, , France

Site Status NOT_YET_RECRUITING

Herzzentrum Leipzig

Leipzig, , Germany

Site Status NOT_YET_RECRUITING

Semmelweis University

Budapest, , Hungary

Site Status NOT_YET_RECRUITING

Bologna University Hospital

Bologna, , Italy

Site Status NOT_YET_RECRUITING

University Hospital Maastricht

Maastricht, , Netherlands

Site Status NOT_YET_RECRUITING

Jagiellonian University

Krakow, , Poland

Site Status NOT_YET_RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario y Politecnico La Fe

Madrid, , Spain

Site Status NOT_YET_RECRUITING

University Hospital Geneva

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

University Hospital of Basel

Basel, , Switzerland

Site Status RECRUITING

Inselspital

Bern, , Switzerland

Site Status RECRUITING

University Hospital of Zurich

Zurich, , Switzerland

Site Status RECRUITING

National Heart and Lung Institute, Imperial College London

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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

Central Contacts

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Haran Burri

Role: CONTACT

Phone: +41794616217

Email: [email protected]

Nikola Kozhuharov

Role: CONTACT

Phone: +41764439086

Email: [email protected]

Facility Contacts

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Helmut Puerfellner

Role: primary

Hein Heidbuchel

Role: primary

Vassil Traykov

Role: primary

Karol Curila

Role: primary

Jaarko Karvonen

Role: primary

Fréderic Anselme

Role: primary

Kerstin Bode

Role: primary

Role: backup

Laszlo Geller

Role: primary

Mauro Biffi

Role: primary

Kevin Vernooy

Role: primary

Marek Jastrzebski

Role: primary

Jose Merino

Role: primary

Oscar Cano

Role: primary

Haran Burri, Prof.

Role: primary

Philipp Krisai

Role: primary

Nikola Kozhuharov

Role: primary

Alexander Breitenstein

Role: primary

Zachary Whinnett

Role: primary

Other Identifiers

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SNF_32003B_220116

Identifier Type: -

Identifier Source: org_study_id