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

NCT ID: NCT06560047

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1616 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-28
• Study Completion Date: 2039-08-31

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.

Conditions

Atrial Fibrillation; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Catheter ablation

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sam Riahi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sam Riahi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Aalborg Univeristy Hospital

Locations

Aalborg University Hospital, Department of Cardiology

Aalborg, , Denmark

Site Status: RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status: NOT_YET_RECRUITING

Department of Cardiology, Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Department of Cardiology, Herlev-Gentofte University Hospital

Hellerup, , Denmark

Site Status: RECRUITING

Department of Cardiology, Odense University Hospital

Odense, , Denmark

Site Status: NOT_YET_RECRUITING

Department of Cardiology, Zealand University Hospital

Roskilde, , Denmark

Site Status: NOT_YET_RECRUITING

Countries

Denmark

Central Contacts

Anne-Christine Ruwald, MD, PhD

Role: CONTACT

anne.christine.huth.ruwald@regionh.dk

+45 40177181

Sam Riahi, MD, PhD

Role: CONTACT

sar@rn.dk

Facility Contacts

Sam Riahi, MD, PhD

Role: primary

sar@rn.dk

Ditte Hansen

Role: backup

ditte.hansen@rn.dk

Henrik Vase, MD, PhD

Role: primary

henvas@rm.dk

Mads Brix Kronborg, MD, PhD

Role: backup

madskron@rm.dk

Anne-Christine Ruwald, MD, PhD

Role: primary

anne.christine.huth.ruwald@regionh.dk

+4540177181

Lars Køber, MD, DMSc

Role: backup

lars.kober@regionh.dk

Morten Schou, MD, PhD

Role: primary

morten.schou.04@regionh.dk

Morten Lock Hansen, MD, PhD

Role: backup

morten.lock.hansen@regionh.dk

Jens Brock Johansen, MD, PhD

Role: primary

brock@dadlnet.dk

Lisbeth Anthonsen, MD, PhD

Role: backup

lisbeth.antonsen@rsyd.dk

Uffe Gang, MD, PhD

Role: primary

ujg@regionsjaelland.dk

Other Identifiers

F2024-063

Identifier Type: OTHER

Identifier Source: secondary_id

N-20240001

Identifier Type: -

Identifier Source: org_study_id