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

ConditionsAtrial Fibrillation, PersistentHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Hospital, Geneva

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conduction system pacing

    Device

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

  • Atrioventricular nodal ablation

    Procedure/Surgery

    Catheter ablation of the atrioventricular node

  • Atrial fibrillation ablation

    Procedure/Surgery

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

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Atrial fibrillation ablationOther 1 intervention
Group B: Conduction system pacing + atrioventricular nodal ablationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Superiority endpoint

Incidence of mortality and cardiovascular hospitalization in each arm

Time frame
1-4 years
2

Non-inferiority endpoint

Incidence of mortality and heart failure hospitalization in each arm

Time frame
1-4 years

Secondary outcomes

1

Minnesota Living with Heart Failure quality of life measure

The questionnaire is comprised of 21 questions around physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. The patient marks a 0-5 scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is scored by summation of all 21 responses (the higher the score, the worse the quality of life).

Time frame
1 year
2

Left ventricular ejection fraction

Measurement using echocardiography

Time frame
1 year
3

Complications

Peri-procedural and long-term

Time frame
1-4 years
4

NYHA class

New York Heart Association classification of heart failure symptoms

Time frame
1-4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Geneva

Lead sponsor

Swiss National Science Foundation

Collaborator

Source ClinicalTrials.gov
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