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NCT Number: NCT06560047

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Department of Cardiology, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Patient unwilling/unable to give informed consent for study participation

Treatment and study plan

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.

Primary outcomes

  1. Time to hospitalization for worsening HF or cardiovascular death

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

    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.

Secondary outcomes

  1. Time to cardiovascular death

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

    Time from randomization to cardiovascular death. Cardiovascular death will be defined as in the primary endpoint.

  2. Time to all-cause mortality

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

    Time from randomization to all-cause mortality

  3. Time to first heart failure hospitalization

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

    Time from randomization to first hospitalization for heart failure, as defined in the primary endpoint

  4. Time to first-time AF hospitalization

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

    Time from randomization to first hospitalization for AF

  5. Time to primary outcome stratified by age

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

    Time from randomization to trial primary outcome stratified by median age at baseline

  6. Time to primary outcome stratified by sex

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

    Time from randomization to trial primary outcome stratified by sex

  7. Time to primary outcome stratified by symptomatic and asymptomatic AF

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

    Time from randomization to trial primary outcome stratified by whether patients have symptomatic or asymptomatic AF at baseline

  8. Time to primary outcome stratified by paroxysmal or persistent AF

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

    Time from randomization to trial primary outcome stratified by paroxysmal or persistent AF at baseline

  9. Time to primary outcome stratified by left ventricular ejection fraction (LVEF)

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

    Time from randomization to trial primary outcome stratified by LVEF <=40% and LVEF>40% at baseline

  10. Change in Quality of Life

    Time frame: From baseline to 12 months

    Change in Quality of Life will be assessed through Kansas City Cardiomyopathy Questionnaire (KCCQ-23) at baseline and 12 months.

    The KCCQ-23 quantifies physical function/limitations, symptoms, quality of life, social function/limitations and self-efficacy. Scores are generated for each domain and scaled from 0 to 100, with higher scores reflecting better health outcome.

  11. Change in self-assessed health

    Time frame: From baseline to 12 months

    Change in self-assessed health will be assessed through short form-36 (SF-36) questionnaire at baseline and 12 months.

    The SF-36 questionnaire consists of 8 domains: Physical functioning, limitions due to physical health, limitations due to emotional problems, fatigue, emotional well-being, social functioning, general bodily pain and general health. Each domain is scored from 0 to 100, with higher scores reflecting better self-assessed health.

  12. Change in New York Heart Association (NYHA) class

    Time frame: From baseline to 12 months

    Change in NYHA class assessed at baseline and 12 months visit

  13. Change in European Heart Rhythm Association score of atrial fibrillation (EHRA class)

    Time frame: From baseline to 12 months

    Change in EHRA class assessed at baseline and 12 months visit

Other outcomes

  1. Change in LVEF

    Time frame: From baseline to 12 months

    Change in LVEF assessed at baseline echocardiography and 12 months echocardiography

  2. Change in left ventricular (LV) volume

    Time frame: From baseline to 12 months

    Change in LV volume assessed at baseline echocardiography and 12 months echocardiography

  3. Change in left atrial (LA) volume

    Time frame: From baseline to 12 months

    Change in LA volume assessed at baseline echocardiography and 12 months echocardiography

  4. Change in NT-pro-BNP

    Time frame: From baseline to 12 months

    Change in NT-pro-BNP assessed at baseline and 12 month

  5. Time to hospitalization or death due to stroke

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

    Time from randomization to hospitalization or death due to stroke

  6. Cumulative heart failure hospitalization

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

    Total cumulative number (first and recurrent) of hospitalization for heart failure from randomization to study completion.

  7. Cumulative hospitalizations for AF

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

    Total cumulative number (first and recurrent) of hospitalization for AF from randomization to study completion.

  8. Time to first-time all-cause hospitalization

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

    Time from randomization to first all-cause hospitalization

  9. Cumulative all-cause hospitalizations

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

    Total cumulative number (first and recurrent) of all-cause hospitalization from randomization to study completion.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Christine Ruwald, MD, PhD

CONTACT

[email protected]

+45 40177181

Sam Riahi, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Herlev and Gentofte Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark
  • Zealand University Hospital

Registry information

Official study title

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

Acronym: DanAblate-HF

Important dates

Study start
2024
Primary completion
2029
Study completion
2039
First posted
Aug 19, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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