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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

• 18 years ≤ Age \<80 years

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

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

Locations
Other Locations
Denmark
Aalborg University Hospital, Department of Cardiology
RECRUITING
Aalborg
Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Department of Cardiology, Rigshospitalet
RECRUITING
Copenhagen
Department of Cardiology, Herlev-Gentofte University Hospital
RECRUITING
Hellerup
Department of Cardiology, Odense University Hospital
NOT_YET_RECRUITING
Odense
Department of Cardiology, Zealand University Hospital
NOT_YET_RECRUITING
Roskilde
Contact Information
Primary
Anne-Christine Ruwald, MD, PhD
anne.christine.huth.ruwald@regionh.dk
+45 40177181
Backup
Sam Riahi, MD, PhD
sar@rn.dk
Time Frame
Start Date: 2024-08-28
Estimated Completion Date: 2039-08-31
Participants
Target number of participants: 1616
Treatments
Other: 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.
No_intervention: Standard treatment
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.
Sponsors
Collaborators: Zealand University Hospital, Odense University Hospital, Herlev and Gentofte Hospital, Aarhus University Hospital, Rigshospitalet, Denmark
Leads: Aalborg University Hospital

This content was sourced from clinicaltrials.gov