NCT06207383 Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
| NCT ID | NCT06207383 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Geneva |
| Condition | Atrial Fibrillation, Persistent |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2024-10-01 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06207383 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Atrial Fibrillation, Persistent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06207383 currently recruiting?
Yes, NCT06207383 is actively recruiting participants. Contact the research team at haran.burri@hcuge.ch for enrollment information.
Where is the NCT06207383 trial being conducted?
This trial is being conducted at Graz, Austria, Antwerp, Belgium, Sofia, Bulgaria, Prague, Czechia and 11 additional locations.
Who is sponsoring the NCT06207383 clinical trial?
NCT06207383 is sponsored by University Hospital, Geneva. The trial plans to enroll 220 participants.
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