NCT06560047

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,616 (estimated)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Catheter ablation	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.

Timeline

• Start date: 2024-08-28
• Primary completion: 2029-08-31
• Completion: 2039-08-31
• First posted: 2024-08-19
• Last updated: 2024-08-30

Locations

6 sites across 1 country: Denmark