Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure (DanAblate-HF)

Aalborg University Hospital

Status: Enrolling

Conditions: Atrial Fibrillation; Heart Failure

Treatments: Procedure: Catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06560047

F2024-063 (Other Identifier)

N-20240001

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,616 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,616 participants in 2 patient groups

Catheter Ablation

Other group

Description:

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.

Treatment:

Procedure: Catheter ablation

Standard treatment

No Intervention group

Description:

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.