An interventional study of Catheter ablation in Atrial Fibrillation and Heart Failure, sponsored by Aalborg University Hospital. Recruiting at 6 sites in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-30.
Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Treatment
The DanAblate-HF trial will investigate whether early catheter ablation treatment for atrial fibrillation in patients with heart failure is superior to standard treatment.
Atrial fibrillation (AF) is the most common arrhythmia in patients with heart failure (HF), with rates ranging between 20-65%, depending on age, severity of HF, subtypes of HF and duration of HF. The two conditions have an intricate and often overlapping pathophysiology, with each condition leading to development of the other, as well as progression of disease. Studies have shown that the presence of AF in HF patients is associated with increased morbidity and mortality, deterioration in HF, exacerbated HF symptoms, and reduced quality of life. The optimal treatment of AF in the presence of HF remains unknown. Currently, there is a pull towards catheter ablation as first-line therapy for AF in HF patients. However, there is no solid scientific evidence to support this approach. Furthermore, it is unknown whether early rhythm control by catheter ablation in HF patients is beneficial.
The investigators aim to conduct a pragmatic, randomized clinical trial designed to evaluate the efficacy and safety of early catheter ablation for AF in patients with HF compared with standard treatment.
Eligible patients with HF and AF will be prospectively screened from all Danish hospitals and randomized 1:1 to early catheter ablation with pulmonary vein isolation (within 6 weeks) or standard guideline directed treatment for AF. Patients with reversible causes for AF, conditions that preclude the use of catheter ablation or previous catheter ablation for AF will be excluded from the study. Randomization and follow-up will be conducted at six specialized sites in Denmark. There will be one scheduled on-site 12-months follow-up visit after randomization. All clinical follow-up will be conducted at the patient's local hospital, according to standard practice and out of trial setting. Information regarding hospital visits/admissions, events, adverse events, changes in medication, cross-over, heart rhythm and rate, and results of relevant blood-work will be ascertained through systematic patient chart-review at pre-specified time-points. The results from this trial will mold future treatment of AF in HF patients. The investigators hypothesize that early catheter ablation reduces the risk of HF hospitalizations and mortality when compared with standard treatment, thereby significantly improving the clinical prognosis for patients with HF and AF.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 1,616 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 42 are open to participants now.
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HF patients with AF within the past 12 months
HF is defined as all of the below (all must apply)
AF is defined as one or more of the following:
A. Symptomatic AF, documented by ECG, Holter of CIED
B. Asymptomatic AF with one or more of the following:
Exclusion Criteria:
Patients randomized to the intervention will undergo early catheter ablation with pulmonary vein isolation as treatment for AF. Catheter ablation should be conducted within 6 weeks of randomization.
Procedure: Catheter ablation
Patients randomized to standard treatment will receive standard guideline directed treatment for AF and HF. Treatment will be initiated at the baseline visit and further clinical follow-up will be conducted at the patients local hospital. Patient will be treated with either rhythm (excluding catheter ablation) or rate control. The choice of treatment strategy will be at the discretion of the treating physician according to current guideline recommendations. If rate control is chosen, patients should have a resting heart rate \< 110 beats per minutes. Rate control can be obtained by medical treatment with digoxin, beta-blockers and if needed amiodarone, in combination or as single treatment. Rhythm control will be conducted through cardioversion and/or medical treatment with amiodarone. Catheter ablation will not be part of the treatment choices in the standard treatment arm.
Catheter ablation with pulmonary vein isolation will be the study intervention. Patients randomized to the intervention arm will undergo catheter ablation within six weeks of randomization. In the waiting-time for ablation, patients will receive standard treatment for AF and HF, as per current guideline recommendations. Catheter ablation will be performed at one of six high-volume ablation centers in Denmark. Mode of catheter ablation will be at the discretion of the operator. Radiofrequency ablation, cryo-balloon ablation and pulsed-field ablation will be utilized. The treating physician should ensure successful pulmonary vein isolation after ablation with either post-procedural mapping or pacing, as per current standards. Only pulmonary vein isolation will be performed during the ablation procedure.
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.
Time frame: From baseline to study completion, with a minimum of 1 year
Time to cardiovascular death
Time from randomization to cardiovascular death. Cardiovascular death will be defined as in the primary endpoint.
Time frame: From baseline to study completion, with a minimum of 1 year
Time to all-cause mortality
Time from randomization to all-cause mortality
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 12 months
Change in New York Heart Association (NYHA) class
Change in NYHA class assessed at baseline and 12 months visit
Time frame: 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
Time frame: From baseline to 12 months
Change in LVEF
Change in LVEF assessed at baseline echocardiography and 12 months echocardiography
Time frame: From baseline to 12 months
Change in left ventricular (LV) volume
Change in LV volume assessed at baseline echocardiography and 12 months echocardiography
Time frame: From baseline to 12 months
Change in left atrial (LA) volume
Change in LA volume assessed at baseline echocardiography and 12 months echocardiography
Time frame: From baseline to 12 months
Change in NT-pro-BNP
Change in NT-pro-BNP assessed at baseline and 12 month
Time frame: From baseline to 12 months
Time to hospitalization or death due to stroke
Time from randomization to hospitalization or death due to stroke
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From baseline to study completion, with a minimum of 1 year
Plan to share: No
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Started Aug 2024 (actual). Primary completion is estimated for Aug 2029, 60 months after the start.
Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 60 months is above that.
Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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