Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAalborg University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
HF patients with AF within the past 12 months
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Catheter ablation
Procedure/SurgeryCatheter 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.
Treatment groups
1,616 Participants
are divided into 2 treatment groupsGroup A: Catheter AblationOther 1 intervention
Group B: Standard treatmentNo intervention 0 interventions
Trial outcomes
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.
Time frame
From baseline to study completion, with a minimum of 1 yearSecondary outcomes
1
Time to cardiovascular death
Time from randomization to cardiovascular death. Cardiovascular death will be defined as in the primary endpoint.
Time frame
From baseline to study completion, with a minimum of 1 year2
Time to all-cause mortality
Time from randomization to all-cause mortality
Time frame
From baseline to study completion, with a minimum of 1 year3
Time to first heart failure hospitalization
Time from randomization to first hospitalization for heart failure, as defined in the primary endpoint
Time frame
From baseline to study completion, with a minimum of 1 year4
Time to first-time AF hospitalization
Time from randomization to first hospitalization for AF
Time frame
From baseline to study completion, with a minimum of 1 yearOther outcomes
1
Change in LVEF
Change in LVEF assessed at baseline echocardiography and 12 months echocardiography
Time frame
From baseline to 12 months2
Change in left ventricular (LV) volume
Change in LV volume assessed at baseline echocardiography and 12 months echocardiography
Time frame
From baseline to 12 months3
Change in left atrial (LA) volume
Change in LA volume assessed at baseline echocardiography and 12 months echocardiography
Time frame
From baseline to 12 months4
Change in NT-pro-BNP
Change in NT-pro-BNP assessed at baseline and 12 month
Time frame
From baseline to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aalborg University Hospital
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Odense University Hospital
Collaborator
Aarhus University Hospital
Collaborator
Zealand University Hospital
Collaborator
Herlev and Gentofte Hospital
Collaborator
Source ClinicalTrials.gov