Catheter ablation of atrial fibrillation compared to conduction system stimulation with ablation of the atrioventricular node in heart failure patients with persistent atrial fibrillation
Zusammenfassung der Studie
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)
Untersuchte Intervention
• 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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
• 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)
Studienstandort
Basel, Bern, Genf, Zürich
(BASEC)
Sponsor
Service de cardiologie Hôpitaux Universitaires de Genève
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof Haran Burri
+41795533710
haran.burri@clutterhug.chService de cardiologie Hôpitaux Universitaires de Genève
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
16.09.2024
(BASEC)
ICTRP Studien-ID
NCT06207383 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Catheter ABlation of Atrial fibrillation versus atrioventricular nodal ablation with CondUction System pacing in persistent atrial fibrillation and heart failure (ABACUS) (BASEC)
Wissenschaftlicher Titel
Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure (ICTRP)
Öffentlicher Titel
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure (ICTRP)
Untersuchte Krankheit(en)
Atrial Fibrillation, Persistent;Heart Failure (ICTRP)
Untersuchte Intervention
Device: Conduction system pacing;Procedure: Atrioventricular nodal ablation;Procedure: Atrial fibrillation ablation (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
17.12.2023 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Swiss National Science Foundation (ICTRP)
Weitere Kontakte
Haran Burri, haran.burri@hcuge.ch, +41794616217 (ICTRP)
Sekundäre IDs
SNF_32003B_220116 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06207383 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar