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

NCT06560047 | Recruiting DMC

• 2 other identifiers: N-20240001F2024-063
• Study Type: interventional
• Target: 1,616
• Locations: 1 country
• Sites: 6

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.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

Heart failure; Atrial fibrillation; Catheter ablation; Treatment; Outcome

Outcome Measures

Primary Outcomes (1)

• Time to hospitalization for worsening HF or cardiovascular death

  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.

  From baseline to study completion, with a minimum of 1 year

Secondary Outcomes (13)

• Time to cardiovascular death

  From baseline to study completion, with a minimum of 1 year

• Time to all-cause mortality

  From baseline to study completion, with a minimum of 1 year

• Time to first heart failure hospitalization

  From baseline to study completion, with a minimum of 1 year

• Time to first-time AF hospitalization

  From baseline to study completion, with a minimum of 1 year

• Time to primary outcome stratified by age

  From baseline to study completion, with a minimum of 1 year

Other Outcomes (9)

• Change in LVEF

  From baseline to 12 months

• Change in left ventricular (LV) volume

  From baseline to 12 months

• Change in left atrial (LA) volume

  From baseline to 12 months

Study Arms (2)

Catheter Ablation

OTHER

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.

Procedure: Catheter ablation

Standard treatment

NO INTERVENTION

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.

Interventions

Catheter ablation 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.

Catheter Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Zealand University Hospital: collaborator
• Herlev and Gentofte Hospital: collaborator

Study Sites (6)

Aalborg University Hospital, Department of Cardiology

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

NOT YET RECRUITING

Department of Cardiology, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Department of Cardiology, Herlev-Gentofte University Hospital

Hellerup, 2900, Denmark

RECRUITING

Department of Cardiology, Odense University Hospital

Odense, 5000, Denmark

NOT YET RECRUITING

Department of Cardiology, Zealand University Hospital

Roskilde, 4000, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Sam Riahi, MD, PhD

  Department of Cardiology, Aalborg Univeristy Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Christine Ruwald, MD, PhD

CONTACT

+45 40177181; anne.christine.huth.ruwald@regionh.dk

Sam Riahi, MD, PhD

CONTACT

sar@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The DanAblate-HF trial is a pragmatic, investigator-initiated, prospective, multicenter, open-labeled, randomized, controlled trial. Patients will be randomized 1:1 to either early catheter ablation or standard treatment.

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2039
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)