NCT06207383Recruiting
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure
Catheter ABlation of Atrial Fibrillation Versus Atrioventricular Nodal Ablation with CondUction System Pacing in Persistent Atrial Fibrillation and Heart Failure
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 17 Dec 2023
- Start date
- 1 Oct 2024
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- University Hospital, Geneva
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT06207383
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 1 Oct 2024 to the primary completion date, 30 Jun 2028
- 18 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (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.
Other
- (vi) Participation in another controlled trial. (vii) Inability to sign and informed consent form.
Who the study is looking for
- (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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Elisabeth sister's Hospital Coordinator of this site? Confirm its status | Graz | Austria | Not yet recruiting |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Antwerp | Belgium | Not yet recruiting |
| Acibadem City Clinic Tokuda University Hospital Coordinator of this site? Confirm its status | Sofia | Bulgaria | Not yet recruiting |
| University Hospital of Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Inselspital Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| University Hospital Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
| University Hospital of Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| University Hospital Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Herzzentrum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario y Politecnico La Fe Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Heart and Lung Center, University of Helsinki Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Not yet recruiting |
| National Heart and Lung Institute, Imperial College London Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Not yet recruiting |
| Bologna University Hospital Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Not yet recruiting |
| Jagiellonian University Coordinator of this site? Confirm its status | Krakow | Poland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.