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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
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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.
Aim To compare clinical outcome with a strategy of conduction system pacing and atrioventricular nodal ablation (CSP+AVNA), versus atrial fibrillation (AF) ablation by pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) and heart failure (HF), to guide future management of these patients.
Hypotheses
Design Investigator-initiated, prospective randomized, controlled, open-label, multicentre study conducted in ~ 30 centres from 14 countries in Europe with expertise in CSP and AF ablation.
Sample size 220 patients
Study duration 4 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial fibrillation ablation | Other | Catheter ablation of atrial fibrillation using technique at the investigator's discretion but including pulmonary vein isolation as an endpoint. |
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| Conduction system pacing + atrioventricular nodal ablation | Active Comparator | Conduction system pacing (either His bundle pacing or left bundle branch area pacing) with catheter ablation of the atrioventricular node. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conduction system pacing | Device | Conduction system pacing (either His bundle pacing or left bundle branch area pacing) |
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| Measure | Description | Time Frame |
|---|---|---|
| Superiority endpoint | Incidence of mortality and cardiovascular hospitalization in each arm | 1-4 years |
| Non-inferiority endpoint | Incidence of mortality and heart failure hospitalization in each arm | 1-4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haran Burri | Contact | +41794616217 | haran.burri@hcuge.ch | |
| Nikola Kozhuharov | Contact | +41764439086 | nikola.kozhuharov@googlemail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Elisabeth sister's Hospital | Not yet recruiting | Graz | Austria |
Data repository
After study closure
Request to study P.I.
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| Atrioventricular nodal ablation | Procedure | Catheter ablation of the atrioventricular node |
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| Atrial fibrillation ablation | Procedure | Catheter ablation of atrial fibrillation with pulmonary vein isolation (using technique of operator's choice, with additional lesions if deemed necessary) |
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| 1 year |
| Left ventricular ejection fraction | Measurement using echocardiography | 1 year |
| Complications | Peri-procedural and long-term | 1-4 years |
| NYHA class | New York Heart Association classification of heart failure symptoms | 1-4 years |
| Cost-Effectiveness Analysis | Evaluation of clinical outcomes and associated costs between between the study arms. This evaluation will be conducted from a societal perspective, capturing both the direct medical costs and the broader societal impacts of the interventions. | 1-4 years |
| Antwerp University Hospital | Not yet recruiting | Antwerp | Belgium |
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| Acibadem City Clinic Tokuda University Hospital | Not yet recruiting | Sofia | Bulgaria |
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| University Hospital, Kralovske Vinohrady | Not yet recruiting | Prague | Czechia |
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| Heart and Lung Center, University of Helsinki | Recruiting | Helsinki | Finland |
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| Hôpital Charles Nicolle | Not yet recruiting | Rouen | France |
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| Herzzentrum Leipzig | Not yet recruiting | Leipzig | Germany |
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| Semmelweis University | Not yet recruiting | Budapest | Hungary |
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| Bologna University Hospital | Not yet recruiting | Bologna | Italy |
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| University Hospital Maastricht | Not yet recruiting | Maastricht | Netherlands |
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| Jagiellonian University | Not yet recruiting | Krakow | Poland |
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| Hospital Universitario La Paz | Not yet recruiting | Madrid | Spain |
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| Hospital Universitario y Politecnico La Fe | Not yet recruiting | Madrid | Spain |
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| University Hospital Geneva | Recruiting | Geneva | Canton of Geneva | 1211 | Switzerland |
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| University Hospital of Basel | Recruiting | Basel | Switzerland |
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| Inselspital | Recruiting | Bern | Switzerland |
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| University Hospital of Zurich | Recruiting | Zurich | Switzerland |
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| National Heart and Lung Institute, Imperial College London | Not yet recruiting | London | United Kingdom |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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