Catheter ablation of atrial fibrillation compared to conduction system stimulation with ablation of the atrioventricular node in heart failure patients with persistent atrial fibrillation
Résumé de l'étude
In this study, we compare two treatment strategies for persistent atrial fibrillation associated with heart failure. If you decide to participate, you will be part of either the intervention group or the control group. You will be randomly assigned to one of the two groups. You will know which group you belong to. In the intervention group, you will be treated with the method of conduction system stimulation by a pacemaker and catheter ablation of the atrioventricular node. In the control group, you will be treated with catheter ablation of the pulmonary veins. We will invite you to three consultations during the first year and then to two annual consultations as part of the study. These appointments are part of standard treatment and are conducted independently of your participation in the study. In addition to the usual pacemaker follow-up, a medical questionnaire will need to be completed during visits, and an echocardiogram will be performed at the one-year follow-up.
(BASEC)
Intervention étudiée
• Group 1 (intervention group) is treated with the implantation of a pacemaker with conduction system stimulation, followed by catheter ablation of the atrioventricular node. • Group 2 (control group) is treated with catheter ablation of the pulmonary veins aimed at restoring and maintaining a normal heart rhythm.
(BASEC)
Maladie en cours d'investigation
Atrial fibrillation
(BASEC)
• Persistent AF with symptomatic HF despite appropriate medical treatment for AF ablation, with at most one prior PVI procedure. Persistent AF is defined as AF that lasts continuously for more than seven days, including episodes terminated by cardioversion (medication or electrical) after > 7 days. • At least one prior hospitalization or emergency department/clinic visit for HF in the last 2 years, with NT-pro-BNP > 1,000 pg/ml or BNP > 250 pg/ml measured at any time during this interval. • Prior or current rate or rhythm control medication. • Age > 60 years (BASEC)
Critères d'exclusion
• NYHA Class IV and systolic blood pressure ≤80 mmHg despite optimized therapy. • Life expectancy < 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 CRT device or pacemaker. Implantable cardioverter defibrillator (ICD) implantation without a pacing indication is acceptable. • Participation in another controlled trial. • Inability to sign an informed consent form. (BASEC)
Lieu de l’étude
Bâle, Berne, Genève, Zurich
(BASEC)
Sponsor
Service de cardiologie Hôpitaux Universitaires de Genève
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof Haran Burri
+41795533710
haran.burri@clutterhug.chService de cardiologie Hôpitaux Universitaires de Genève
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Genève
(BASEC)
Date d'approbation du comité d'éthique
16.09.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06207383 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Catheter ABlation of Atrial fibrillation versus atrioventricular nodal ablation with CondUction System pacing in persistent atrial fibrillation and heart failure (ABACUS) (BASEC)
Titre académique
Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure (ICTRP)
Titre public
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure (ICTRP)
Maladie en cours d'investigation
Atrial Fibrillation, Persistent;Heart Failure (ICTRP)
Intervention étudiée
Device: Conduction system pacing;Procedure: Atrioventricular nodal ablation;Procedure: Atrial fibrillation ablation (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 60 Years
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. (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Superiority endpoint;Non-inferiority endpoint (ICTRP)
Minnesota Living with Heart Failure quality of life measure;Left ventricular ejection fraction;Complications;NYHA class;Cost-Effectiveness Analysis (ICTRP)
Date d'enregistrement
17.12.2023 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
Swiss National Science Foundation (ICTRP)
Contacts supplémentaires
Haran Burri, haran.burri@hcuge.ch, +41794616217 (ICTRP)
ID secondaires
SNF_32003B_220116 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06207383 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible