Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure
NCT Number: NCT06560047
Acronym: DanAblate-HF
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Fibrillation|Heart Failure
Interventions: PROCEDURE: Catheter ablation
Sponsor: Aalborg University Hospital
Collaborators: Rigshospitalet, Denmark|Odense University Hospital|Aarhus University Hospital|Zealand University Hospital|Herlev and Gentofte Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1616
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2039-08-31
Locations: Aalborg University Hospital, Department of Cardiology, Aalborg, 9000, Denmark|Aarhus University Hospital, Aarhus, 8200, Denmark|Department of Cardiology, Rigshospitalet, Copenhagen, 2100, Denmark|Department of Cardiology, Herlev-Gentofte University Hospital, Hellerup, 2900, Denmark|Department of Cardiology, Odense University Hospital, Odense, 5000, Denmark|Department of Cardiology, Zealand University Hospital, Roskilde, 4000, Denmark

Summary:
The DanAblate-HF trial will investigate whether early catheter ablation treatment for atrial fibrillation in patients with heart failure is superior to standard treatment.

Primary Outcome Measures: Time to hospitalization for worsening HF or cardiovascular death, The primary outcome of the trial is defined as the time from randomization to the composite of one the following, whichever comes first

* Hospitalization for worsening HF
* Cardiovascular (CV) mortality

Hospitalization for worsening HF will be defined as hospital admission primarily for HF (as deemed so by the event adjudication committee) with a duration of at least 24 hours and requiring intensification of diuretic treatment.

CV mortality will be defined as all deaths resulting from one or more of the following: HF, stroke, acute myocardial infarction, CV procedural deaths, CV hemorrhage, arrythmia, sudden cardiac death, death due to other CV causes and death of undetermined cause., From baseline to study completion, with a minimum of 1 year
Secondary Outcome Measures: Time to cardiovascular death, Time from randomization to cardiovascular death. Cardiovascular death will be defined as in the primary endpoint., From baseline to study completion, with a minimum of 1 year|Time to all-cause mortality, Time from randomization to all-cause mortality, From baseline to study completion, with a minimum of 1 year|Time to first heart failure hospitalization, Time from randomization to first hospitalization for heart failure, as defined in the primary endpoint, From baseline to study completion, with a minimum of 1 year|Time to first-time AF hospitalization, Time from randomization to first hospitalization for AF, From baseline to study completion, with a minimum of 1 year|Time to primary outcome stratified by age, Time from randomization to trial primary outcome stratified by median age at baseline, From baseline to study completion, with a minimum of 1 year|Time to primary outcome stratified by sex, Time from randomization to trial primary outcome stratified by sex, From baseline to study completion, with a minimum of 1 year|Time to primary outcome stratified by symptomatic and asymptomatic AF, Time from randomization to trial primary outcome stratified by whether patients have symptomatic or asymptomatic AF at baseline, From baseline to study completion, with a minimum of 1 year|Time to primary outcome stratified by paroxysmal or persistent AF, Time from randomization to trial primary outcome stratified by paroxysmal or persistent AF at baseline, From baseline to study completion, with a minimum of 1 year|Time to primary outcome stratified by left ventricular ejection fraction (LVEF), Time from randomization to trial primary outcome stratified by LVEF \<=40% and LVEF\>40% at baseline, From baseline to study completion, with a minimum of 1 year|Change in Quality of Life, Change in Quality of Life will be assessed through Kansas City Cardiomyopathy Questionnaire (KCCQ-23) at baseline and 12 months.

The KCCQ-23 quantifies physical function/limitations, symptoms, quality of life, social function/limitations and self-efficacy. Scores are generated for each domain and scaled from 0 to 100, with higher scores reflecting better health outcome., From baseline to 12 months|Change in self-assessed health, Change in self-assessed health will be assessed through short form-36 (SF-36) questionnaire at baseline and 12 months.

The SF-36 questionnaire consists of 8 domains: Physical functioning, limitions due to physical health, limitations due to emotional problems, fatigue, emotional well-being, social functioning, general bodily pain and general health. Each domain is scored from 0 to 100, with higher scores reflecting better self-assessed health., From baseline to 12 months|Change in New York Heart Association (NYHA) class, Change in NYHA class assessed at baseline and 12 months visit, From baseline to 12 months|Change in European Heart Rhythm Association score of atrial fibrillation (EHRA class), Change in EHRA class assessed at baseline and 12 months visit, From baseline to 12 months
Other Outcome Measures: Change in LVEF, Change in LVEF assessed at baseline echocardiography and 12 months echocardiography, From baseline to 12 months|Change in left ventricular (LV) volume, Change in LV volume assessed at baseline echocardiography and 12 months echocardiography, From baseline to 12 months|Change in left atrial (LA) volume, Change in LA volume assessed at baseline echocardiography and 12 months echocardiography, From baseline to 12 months|Change in NT-pro-BNP, Change in NT-pro-BNP assessed at baseline and 12 month, From baseline to 12 months|Time to hospitalization or death due to stroke, Time from randomization to hospitalization or death due to stroke, From baseline to study completion, with a minimum of 1 year|Cumulative heart failure hospitalization, Total cumulative number (first and recurrent) of hospitalization for heart failure from randomization to study completion., From baseline to study completion, with a minimum of 1 year|Cumulative hospitalizations for AF, Total cumulative number (first and recurrent) of hospitalization for AF from randomization to study completion., From baseline to study completion, with a minimum of 1 year|Time to first-time all-cause hospitalization, Time from randomization to first all-cause hospitalization, From baseline to study completion, with a minimum of 1 year|Cumulative all-cause hospitalizations, Total cumulative number (first and recurrent) of all-cause hospitalization from randomization to study completion., From baseline to study completion, with a minimum of 1 year