Atrial Fibrillation, PersistentRe-AFNCT06845085
Re-ablation of Persistent Atrial Fibrillation
A study testing Intervention in people with Atrial Fibrillation, Persistent, run by Aarhus University Hospital at 3 sites in 3 countries.
Trial summary
Pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line will be compared to pulmonary vein re-isolation alone in patients undergoing re-ablation for persistent atrial fibrillation in this investigator initiated, randomized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Persistent
- What is being tested?
- Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2025to Oct 2032
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous pulmonary vein isolation for atrial fibrillation
- Indication for catheter ablation with at least two episodes of symptomatic PsAF during the last 12 months
- Age > 18 years
- Expected survival > 12 months
- Able to provide informed consent
Who cannot join
- Previous extrapulmonary atrial ablation other than cavotricuspid isthmus line, roof- or dome line or posterior wall isolation/ablation
- Atypical atrial flutter in addition to atrial fibrillation
- Atrial fibrillation secondary to a transient abnormality
- Uncontrolled hypertension
- Acute coronary syndrome, cardiac surgery, or TIA/stroke within the last 3 months
- Planned cardiac surgery within 1 year
- Dialysis or severe renal failure
- Active substance or alcohol abuse (>14 units/week)
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Denmark1 site
Department of Cardiology, Aarhus University Hospital
Århus N, Danmark, 8250
Peter Lukac, MD, PhD, +45 40293641, peteluka@rm.dk
Mads Brix Lukac, MD, PhD, DMSc, +45 29896776, madskron@rm.dk
Netherlands1 site
Department of Cardiology, Leiden University Medical Center
Leiden, 2333
Sebastiaan Piers, MD, PhD, +31 71 526 20 20, S.R.D.Piers@lumc.nl
Sweden1 site
Department of Cardiology, Karolinska University Hospital, Stockholm
Stockholm, 17176
Finn Åkerström, MD, PhD, +46 734646045, finn.akerstrom@regionstockholm.se
About this study
Official title: Re-ablation of Persistent Atrial Fibrillation: a Randomized Study, Evaluating Vein of Marshall Ethanol Ablation in Combination With Block of Mitral and Tricuspid Isthmuses and Dome Line
Pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line will be compared to pulmonary vein re-isolation alone in patients undergoing re-ablation for persistent atrial fibrillation in this investigator initiated, randomized, patient-assessor blinded multicenter trial. Patients are followed with standard ECG at 3 months, with standard ECG, 5-days' ECG monitoring and quality of life assessment after 12 months, with standard ECG and quality of life assessment after 24 months, through patient files at 60 months after the ablation.
Primary endpoint: Change in AFEQT score between baseline and 12 months.
Read the detailed description
This study is a prospective, patient and assessor blinded, 1:1 randomized superiority trial.
Consecutive patients referred for re-ablation of symptomatic PsAF after previous PVI will be included. All preoperative procedures will be conducted according to the department's standard operational procedures for AF ablation. In all patients, an electro anatomical map (CARTO™, Biosense Webster, Diamond Bar, CA, or EnSite X™, Abbott Laboratories, Abbott Park, IL) of the LA with a multipolar mapping catheter (PENTARAY™ or OCTARAY™, Biosense Webster, Diamond Bar, CA, or Advisor™ HD Grid, Abbott Laboratories, Abbott Park, IL) will be constructed and reconnection of PVs will be assessed in sinus rhythm. If reconnection is present, re-PVI will be performed and confirmed with the multipolar mapping catheter. Patients in atrial fibrillation will undergo cardioversion to sinus rhythm prior to mapping. After mapping and confirming isolation of the PVs, patients will be randomized using the Redcap Database software to intervention or control. The intervention group will undergo VOM ethanol ablation including supplementary LA and coronary sinus ablation, if needed to achieve mitral isthmus block plus creation of dome line and cavotricuspid isthmus (CTI) block. VOM ablation, mitral and CTI ablation and dome line will not be performed in control group and patients in control group will undergo no further ablation. The energy source used will be radiofrequency ablation or pulsed field ablation, at the discretion of the physician. However, radiofrequency should be preferred near coronary arteries. For dome line, focal PFA is preferred. All post-procedural work-up and follow-up will be the same for both randomization groups and assessment of outcomes will be performed by personnel blinded to randomization.
Patients are followed with standard ECG at 3 months, with standard ECG, 5-days' ECG monitoring and quality of life assessment after 12 months, with standard ECG and quality of life assessment after 24 months, through patient files at 60 months after the ablation.
Primary endpoint: Change in AFEQT score between baseline and 12 months.
- Conditions
- Atrial Fibrillation, Persistent
- Being tested
- Intervention, Control
- Keywords
- Persistent atrial fibrillation, Radiofrequency ablation, Pulsed field ablation, Vein of Marshall alcohol ablation, Cavotricuspid isthmus line, Mitral isthmus line, Dome line, Pulmonary vein re-isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionProcedure or surgery
pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line
ControlProcedure or surgery
pulmonary vein re-isolation
| Study group | Role | What they receive |
|---|---|---|
| vein re-isolation plus VOM ablation and block of mitral and tricuspid isthmuses and dome line | Experimental | pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line Receives: Procedure: Intervention |
| vein re-isolation | Active comparator | pulmonary vein re-isolation Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Atrial fibrillation effect on quality of life (AFEQT) score
A score with a scale from 0 to 100. The higher score signifies less disability
Measured: between baseline and 12 months
Secondary outcomes (7)
Freedom from documented atrial arrhythmia
As documented on a standard ECG or Holter, after 3 months blanking period, on or off antiarrhythmic drugs
Measured: 12, 24 and 60 months
Freedom from documented persistent atrial arrhythmia
duration 7 days or longer or cardioverted, after 3 months blanking period, on or off antiarrhythmic drugs
Measured: at 12 and 24 months and 5 years
Freedom from direct-current cardioverted atrial arrhythmia
after 3 months blanking period, on or off antiarrhythmic drugs
Measured: at 12 and 24 months and 5 years
Number of direct current-cardioversions and sustained atrial arrhythmia episodes
after 3 months blanking period, on or off antiarrhythmic drugs
Measured: at 12 and 24 months and 5 years
Freedom from accepted chronic atrial fibrillation
i.e. when cardioversion is not considered or indicated
Measured: at 12 and 24 months and 5 years.
Freedom from re-ablation procedure
reablation procedure because of atrial arrhythmia
Measured: at 12 and 24 months and 5 years.
Change in Atrial fibrillation effect on quality of life (AFEQT) score
A score with a scale from 0 to 100. The higher score signifies less disability
Measured: between baseline and 24 months and between baseline and 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lukac, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845085
- Sponsor's protocol ID
- 1-10-72-153-24
- Acronym
- Re-AF
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-ablation of Persistent Atrial Fibrillation: a Randomized Study, Evaluating Vein of Marshall Ethanol Ablation in Combination With Block of Mitral and Tricuspid Isthmuses and Dome Line
- ClinicalTrials.gov ID
- NCT06845085
- Acronym / sponsor ID
- Re-AF / 1-10-72-153-24
- Conditions
- Atrial Fibrillation, Persistent
- Keywords
- Persistent atrial fibrillation, Radiofrequency ablation, Pulsed field ablation, Vein of Marshall alcohol ablation, Cavotricuspid isthmus line, Mitral isthmus line, Dome line, Pulmonary vein re-isolation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Leiden University Medical Center
- Study start
- Mar 2025 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 25 Feb 2025 (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.
Pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line will be compared to pulmonary vein re-isolation alone in patients undergoing re-ablation for persistent atrial fibrillation in this investigator initiated, randomized, patient-assessor blinded multicenter trial. Patients are followed with standard ECG at 3 months, with standard ECG, 5-days' ECG monitoring and quality of life assessment after 12 months, with standard ECG and quality of life assessment after 24 months, through patient files at 60 months after the ablation.
Primary endpoint: Change in AFEQT score between baseline and 12 months.
Detailed description
This study is a prospective, patient and assessor blinded, 1:1 randomized superiority trial.
Consecutive patients referred for re-ablation of symptomatic PsAF after previous PVI will be included. All preoperative procedures will be conducted according to the department's standard operational procedures for AF ablation. In all patients, an electro anatomical map (CARTO™, Biosense Webster, Diamond Bar, CA, or EnSite X™, Abbott Laboratories, Abbott Park, IL) of the LA with a multipolar mapping catheter (PENTARAY™ or OCTARAY™, Biosense Webster, Diamond Bar, CA, or Advisor™ HD Grid, Abbott Laboratories, Abbott Park, IL) will be constructed and reconnection of PVs will be assessed in sinus rhythm. If reconnection is present, re-PVI will be performed and confirmed with the multipolar mapping catheter. Patients in atrial fibrillation will undergo cardioversion to sinus rhythm prior to mapping. After mapping and confirming isolation of the PVs, patients will be randomized using the Redcap Database software to intervention or control. The intervention group will undergo VOM ethanol ablation including supplementary LA and coronary sinus ablation, if needed to achieve mitral isthmus block plus creation of dome line and cavotricuspid isthmus (CTI) block. VOM ablation, mitral and CTI ablation and dome line will not be performed in control group and patients in control group will undergo no further ablation. The energy source used will be radiofrequency ablation or pulsed field ablation, at the discretion of the physician. However, radiofrequency should be preferred near coronary arteries. For dome line, focal PFA is preferred. All post-procedural work-up and follow-up will be the same for both randomization groups and assessment of outcomes will be performed by personnel blinded to randomization.
Patients are followed with standard ECG at 3 months, with standard ECG, 5-days' ECG monitoring and quality of life assessment after 12 months, with standard ECG and quality of life assessment after 24 months, through patient files at 60 months after the ablation.
Primary endpoint: Change in AFEQT score between baseline and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vein re-isolation plus VOM ablation and block of mitral and tricuspid isthmuses and dome line | Experimental | Procedure: Interventionpulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line |
| vein re-isolation | Active comparator | Procedure: Controlpulmonary vein re-isolation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previous pulmonary vein isolation for atrial fibrillation
- Indication for catheter ablation with at least two episodes of symptomatic PsAF during the last 12 months
- Age > 18 years
- Expected survival > 12 months
- Able to provide informed consent
Key exclusion criteria (8 listed)
- Previous extrapulmonary atrial ablation other than cavotricuspid isthmus line, roof- or dome line or posterior wall isolation/ablation
- Atypical atrial flutter in addition to atrial fibrillation
- Atrial fibrillation secondary to a transient abnormality
- Uncontrolled hypertension
- Acute coronary syndrome, cardiac surgery, or TIA/stroke within the last 3 months
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 |
|---|---|---|
| Interventionpulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line | Procedure or surgery | vein re-isolation plus VOM ablation and block of mitral and tricuspid isthmuses and dome line |
| Controlpulmonary vein re-isolation | Procedure or surgery | vein re-isolation |
Primary outcome
Change in Atrial fibrillation effect on quality of life (AFEQT) score
Time frame: between baseline and 12 months
A score with a scale from 0 to 100. The higher score signifies less disability
7 secondary outcomes
Freedom from documented atrial arrhythmia
Time frame: 12, 24 and 60 months
Freedom from documented persistent atrial arrhythmia
Time frame: at 12 and 24 months and 5 years
Freedom from direct-current cardioverted atrial arrhythmia
Time frame: at 12 and 24 months and 5 years
Number of direct current-cardioversions and sustained atrial arrhythmia episodes
Time frame: at 12 and 24 months and 5 years
Freedom from accepted chronic atrial fibrillation
Time frame: at 12 and 24 months and 5 years.
Freedom from re-ablation procedure
Time frame: at 12 and 24 months and 5 years.
Change in Atrial fibrillation effect on quality of life (AFEQT) score
Time frame: between baseline and 24 months and between baseline and 5 years.
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 28 Feb 2025.
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Atrial Fibrillation, Persistent, run by Aarhus University Hospital at 3 sites in 3 countries.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Netherlands, Sweden. 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 Peter Lukac, MD, PhD (+45 40293641, peteluka@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Atrial fibrillation effect on quality of life (AFEQT) score (time frame: between baseline and 12 months). 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 28 Feb 2025.