Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation; Heart Failure
• Interventions: Procedure: Catheter ablation

• Registration Number: NCT06560047
• Lead Sponsor: Aalborg University Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-17
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-20
• Study Start: 2024-09-01
• Primary Completion: 2029-08-31
• Study Completion: 2039-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1616

Inclusion Criteria

1. HF patients with AF within the past 12 months

   HF is defined as all of the below (all must apply)

   • Clinically assessed Heart Failure with Reduced Ejection Fraction (HFrEF)
   • An indication for initiation or ongoing guideline directed medical therapy for HFrEF, according to current Heart Failure guidelines
   • LVEF < 50% at any point during the past 12 months

   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:

   • Clinical indication for rhythm or rate control (documented by ECG, telemetry, Holter, CIED)
   • ≥2 ECG detected AF episodes within 3 months (on separate dates)
   • Holter detected AF with a continuous duration of more than 6 hours
   • CIED detected AF with continuous duration >24 hours

2. 18 years ≤ Age <80 years

3. Optimal medical therapy for HFrEF or planned/current uptitration in guideline directed medical therapy for HFrEF

4. Treatment with anticoagulation for stroke prevention, initiated according to guidelines for treatment of AF

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Exclusion Criteria

1. Life-expectancy < 1 year
2. BMI > 40
3. Contraindications or unacceptable side effects to rate limiting drugs AND amiodarone
4. LA size (indexed for BSA) > 60 ml/m2 (volume) on echo within the last year
5. Documented persistent/permanent AF > 1 year
6. Previous AF ablation/surgery
7. Reversible causes of AF (including, but not limited to, infection within 14 days, untreated thyroid disease, surgery)
8. Severe valvular disease
9. Acute myocardial infarction, cardiothoracic surgery or stroke within the past 3 months
10. Planned cardiothoracic surgery
11. Listed for heart transplant
12. Contraindications for anticoagulation therapy or catheter ablation
13. Severe kidney disease (CKD≥5)
14. Pregnancy
15. Patient unwilling to try medical therapy for AF
16. Patient unwilling/unable to give informed consent for study participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter Ablation	Catheter ablation	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.

Primary Outcome Measures

Name	Time	Method
Time to hospitalization for worsening HF or cardiovascular death	From baseline to study completion, with a minimum of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Time to primary outcome stratified by symptomatic and asymptomatic AF	From baseline to study completion, with a minimum of 1 year	Time from randomization to trial primary outcome stratified by whether patients have symptomatic or asymptomatic AF at baseline
Time to primary outcome stratified by paroxysmal or persistent AF	From baseline to study completion, with a minimum of 1 year	Time from randomization to trial primary outcome stratified by paroxysmal or persistent AF at baseline
Change in self-assessed health	From baseline to 12 months	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.
Change in New York Heart Association (NYHA) class	From baseline to 12 months	Change in NYHA class assessed at baseline and 12 months visit
Time to first-time AF hospitalization	From baseline to study completion, with a minimum of 1 year	Time from randomization to first hospitalization for AF
Time to primary outcome stratified by age	From baseline to study completion, with a minimum of 1 year	Time from randomization to trial primary outcome stratified by median age at baseline
Time to primary outcome stratified by left ventricular ejection fraction (LVEF)	From baseline to study completion, with a minimum of 1 year	Time from randomization to trial primary outcome stratified by LVEF \<=40% and LVEF\>40% at baseline
Change in Quality of Life	From baseline to 12 months	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.
Change in European Heart Rhythm Association score of atrial fibrillation (EHRA class)	From baseline to 12 months	Change in EHRA class assessed at baseline and 12 months visit
Time to cardiovascular death	From baseline to study completion, with a minimum of 1 year	Time from randomization to cardiovascular death. Cardiovascular death will be defined as in the primary endpoint.
Time to all-cause mortality	From baseline to study completion, with a minimum of 1 year	Time from randomization to all-cause mortality
Time to first heart failure hospitalization	From baseline to study completion, with a minimum of 1 year	Time from randomization to first hospitalization for heart failure, as defined in the primary endpoint
Time to primary outcome stratified by sex	From baseline to study completion, with a minimum of 1 year	Time from randomization to trial primary outcome stratified by sex

Trial Locations

Locations (6)

Department of Cardiology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Aalborg University Hospital, Department of Cardiology; 🇩🇰 Aalborg, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Department of Cardiology, Herlev-Gentofte University Hospital; 🇩🇰 Hellerup, Denmark

Department of Cardiology, Odense University Hospital; 🇩🇰 Odense, Denmark

Department of Cardiology, Zealand University Hospital; 🇩🇰 Roskilde, Denmark