Atrial FibrillationDanAblate-HFNCT06560047
Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure
A study testing Catheter ablation in people with Atrial Fibrillation and Heart Failure, run by Aalborg University Hospital at 6 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,616 participants
- Where
- 6 sitesDenmark
- Study dates
- 28 Aug 2024to 31 Aug 2039
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 15Show fewer
- Symptomatic AF, documented by ECG, Holter of CIED
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sam Riahi, MD, PhD contact
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Aalborg University Hospital, Department of Cardiology
Aalborg, 9000
Sam Riahi, MD, PhD, sar@rn.dk
Ditte Hansen, ditte.hansen@rn.dk
- Not yet recruiting
Aarhus University Hospital
Aarhus, 8200
Henrik Vase, MD, PhD, henvas@rm.dk
Mads Brix Kronborg, MD, PhD, madskron@rm.dk
- Recruiting
Department of Cardiology, Rigshospitalet
Copenhagen, 2100
Anne-Christine Ruwald, MD, PhD, +4540177181, anne.christine.huth.ruwald@regionh.dk
Lars Køber, MD, DMSc, lars.kober@regionh.dk
- Recruiting
Department of Cardiology, Herlev-Gentofte University Hospital
Hellerup, 2900
Morten Schou, MD, PhD, morten.schou.04@regionh.dk
Morten Lock Hansen, MD, PhD, morten.lock.hansen@regionh.dk
- Not yet recruiting
Department of Cardiology, Odense University Hospital
Odense, 5000
Jens Brock Johansen, MD, PhD, brock@dadlnet.dk
Lisbeth Anthonsen, MD, PhD, lisbeth.antonsen@rsyd.dk
- Not yet recruiting
Department of Cardiology, Zealand University Hospital
Roskilde, 4000
Uffe Gang, MD, PhD, ujg@regionsjaelland.dk
Uffe Gang, MD, PhD
About this study
Official title: Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure - The DanAblate-HF 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.
Read the 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
- Being tested
- Catheter ablation
- Keywords
- Heart failure, Atrial fibrillation, Catheter ablation, Treatment, Outcome
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to study completion, with a minimum of 1 year
Secondary outcomes (13)
Time to cardiovascular death
Time from randomization to cardiovascular death. Cardiovascular death will be defined as in the primary endpoint.
Measured: From baseline to study completion, with a minimum of 1 year
Time to all-cause mortality
Time from randomization to all-cause mortality
Measured: From baseline to study completion, with a minimum of 1 year
Time to first heart failure hospitalization
Time from randomization to first hospitalization for heart failure, as defined in the primary endpoint
Measured: From baseline to study completion, with a minimum of 1 year
Time to first-time AF hospitalization
Time from randomization to first hospitalization for AF
Measured: From baseline to study completion, with a minimum of 1 year
Time to primary outcome stratified by age
Time from randomization to trial primary outcome stratified by median age at baseline
Measured: From baseline to study completion, with a minimum of 1 year
Time to primary outcome stratified by sex
Time from randomization to trial primary outcome stratified by sex
Measured: From baseline to study completion, with a minimum of 1 year
Time to primary outcome stratified by symptomatic and asymptomatic AF
Time from randomization to trial primary outcome stratified by whether patients have symptomatic or asymptomatic AF at baseline
Measured: From baseline to study completion, with a minimum of 1 year
Time to primary outcome stratified by paroxysmal or persistent AF
Time from randomization to trial primary outcome stratified by paroxysmal or persistent AF at baseline
Measured: From baseline to study completion, with a minimum of 1 year
Time to primary outcome stratified by left ventricular ejection fraction (LVEF)
Time from randomization to trial primary outcome stratified by LVEF <=40% and LVEF>40% at baseline
Measured: From baseline to study completion, with a minimum of 1 year
Change in Quality of Life
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.
Measured: From baseline to 12 months
Change in self-assessed health
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.
Measured: From baseline to 12 months
Change in New York Heart Association (NYHA) class
Change in NYHA class assessed at baseline and 12 months visit
Measured: From baseline to 12 months
Change in European Heart Rhythm Association score of atrial fibrillation (EHRA class)
Change in EHRA class assessed at baseline and 12 months visit
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start28 Aug 2024
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aarhus University Hospital, Zealand University Hospital, Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Sam Riahi, Aalborg University Hospital
- Investigators
- Sam Riahi, MD, PhD, Principal investigator, Department of Cardiology, Aalborg Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560047
- Sponsor's protocol ID
- N-20240001
- Other IDs
- F2024-063
- Acronym
- DanAblate-HF
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Evaluation of Early Catheter Ablation for Atrial Fibrillation in Patients With Heart Failure - The DanAblate-HF Trial
- ClinicalTrials.gov ID
- NCT06560047
- Acronym / sponsor ID
- DanAblate-HF / N-20240001
- Conditions
- Atrial Fibrillation, Heart Failure
- Keywords
- Heart failure, Atrial fibrillation, Catheter ablation, Treatment, Outcome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,616 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aarhus University Hospital, Zealand University Hospital, Herlev and Gentofte Hospital
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2039 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation | Other | Procedure: Catheter ablationPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- HF patients with AF within the past 12 months
- HF is defined as all of the below (all must apply)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationCatheter 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. | Procedure or surgery | Catheter Ablation |
Primary outcome
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.
13 secondary outcomes
Time to cardiovascular death
Time frame: From baseline to study completion, with a minimum of 1 year
Time to all-cause mortality
Time frame: From baseline to study completion, with a minimum of 1 year
Time to first heart failure hospitalization
Time frame: From baseline to study completion, with a minimum of 1 year
Time to first-time AF hospitalization
Time frame: From baseline to study completion, with a minimum of 1 year
Time to primary outcome stratified by age
Time frame: From baseline to study completion, with a minimum of 1 year
Time to primary outcome stratified by sex
Time frame: From baseline to study completion, with a minimum of 1 year
Time to primary outcome stratified by symptomatic and asymptomatic AF
Time frame: From baseline to study completion, with a minimum of 1 year
Time to primary outcome stratified by paroxysmal or persistent AF
Time frame: From baseline to study completion, with a minimum of 1 year
Time to primary outcome stratified by left ventricular ejection fraction (LVEF)
Time frame: From baseline to study completion, with a minimum of 1 year
Change in Quality of Life
Time frame: From baseline to 12 months
Change in self-assessed health
Time frame: From baseline to 12 months
Change in New York Heart Association (NYHA) class
Time frame: From baseline to 12 months
Change in European Heart Rhythm Association score of atrial fibrillation (EHRA class)
Time frame: From baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sam Riahi, MD, PhD contact
Sam Riahi, MD, PhD principal investigator
Department of Cardiology, Aalborg Univeristy Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation in people with Atrial Fibrillation and Heart Failure, run by Aalborg University Hospital at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Christine Ruwald, MD, PhD (+45 40177181, anne.christine.huth.ruwald@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to hospitalization for worsening HF or cardiovascular death (time frame: From baseline to study completion, with a minimum of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.