Atrial Fibrillation, PersistentREPAIR PERS-AFNCT06098989
A Prospective Study of REPeat Ablation In Patients With Recurrent PERSistent Atrial Fibrillation: Pulmonary Vein Isolation vs. Adjunct Posterior Wall Isolation (REPAIR PERS-AF Study)
A study testing Radio frequency ablation in people with Atrial Fibrillation, Persistent and Atrial Fibrillation Recurrent, run by Haukeland University Hospital.
Trial summary
This study aims to investigate the best strategy for repeat ablation of recurrent persistent atrial fibrillation (AF) after previous persistent AF ablation involving pulmonary vein isolation (PVI) along. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Persistent, Atrial Fibrillation Recurrent
- What is being tested?
- Radio frequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 15 Nov 2026
- 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
- Symptomatic patients with persistent AF and indication for repeat ablation
- procedure.
- Patients with recurrent persistent AF (with a duration <3 year, at least one episode longer than 7 days during the last 6 months and have been electrically cardioverted at least once during the last 12 months) after previous catheter ablation.
- Patients with up to two previous catheter ablations for AF are included if the procedures only involved PVI. Previous PVI procedure(s) with both cryoablation and radiofrequency ablation are accepted.
- Patients have taken at least one antiarrhythmic drug.
- Patients are willing to participate in the study and sign the patient information form.
- Age: 18-80 years old.
- Patients must be on continuous anticoagulation with warfarin (INR 2-3) or direct oral anticoagulant for >4 weeks prior to the ablation.
Who cannot join
- Patients with >2 ablation procedures in the LA for AF or atrial flutter
- Previous ablation procedures for AF involving ablation strategies beyond PVI
- Duration of persistent AF >3 years
- Presence of atrial flutter or atrial tachycardia
- Presence of an intracavitary thrombus
- Uncontrolled heart failure
Show all 16Show fewer
- Severe valvular disease
- LA diameter > 60 mm
- Structural heart disease involving more than moderate valvular stenosis and/or
- Insufficiencies
- Rheumatic heart disease
- Cardiac surgery for valvopathy or for congenital heart disease
- Patients with contraindications to systemic anticoagulation
- Severe renal dysfunction
- Patients who are or may potentially be pregnant.
- Patient not able to be followed up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to investigate the best strategy for repeat ablation of recurrent persistent atrial fibrillation (AF) after previous persistent AF ablation involving pulmonary vein isolation (PVI) along. Patients with low voltage areas on the posterer wall will be randomized to PVI alone or the posterer wall isoaltion (PWI) in addition to PVI.
Read the detailed description
This study aims to find a optmal strategy for repeat ablation for recurrent persistent AF after previous persistent AF ablation involving only PVI. PVI is an evident and well documented target for AF ablation. Many other ablation approaches beyond PVI have been reported. PWI is one of the frequently applied methods. However, this appoach has not been studied in randomized clinical trials for recurrent persistent AF after index procedure, thus evidence is demanded for guidance of clinical practice for AF ablation.
The purpose of this study is to clarify this matter by comparing PVI alone strategy with the approach of PVI plus PWI in patients with recurrent persistent AF after index ablation procedure. Since previous clinical studies have shown better outcomes of ablation among patients with normal left atrium (LA) than those with sick LA, ablation strategies in this study will be selected based on voltage mapping of the LA, avoiding unnecessary ablation applications.
The investigators hypothesize that PVI is good enough for patients with normal LA (normal voltage ≥0.5 mV); Among patients with low voltage/scar (voltage < 0.5 mV), PVI plus PWI is superior to PVI alone.
This study is a prospective, multi-center, open-labeled, partly randomized study. After enrollment, patients will receive a voltage mapping of the LA which is routine for all AF ablation procedures. Based on the mapping results, patients will be stratified into two strata, normal voltage (≥ 0.5 mV) and low voltage (< 0.5 mV) in the LA posterior wall. Patients with normal voltage in the LA posterior wall will be directly assigned to arm 1 receiving PVI alone treatment (avoid unnecessary ablation of healthy myocardium). Patients with low voltage will be 1:1 randomized in arms 2 and 3 receiving either PVI alone or PVI + PWI treatment.
- Arm 1: Normal voltage in LA posterior wall - PVI alone
- Arm 2: Low voltage in LA posterior wall - PVI alone
- Arm 3: Low voltage in LA posterior wall - PVI + PWI
Three Norwegian University Hospitals, including Haukeland University Hospital, Bergen, St. Olavs Hospital, Trondheim, and University Hospital of North Norway, Tromsø, will participate in this study. The study is expected to last 3 years, 24 months for enrollment and each patient will be followed for a period of 12 months.
In order to minimize bias, subjects will be randomized next to the LA mapping. Patients will be analyzed according to their initial randomization, that is intention-to-treat, even if they never start the treatment, or discontinue, or cross over the group.
Patents will be followed in out-patient clinic at 3, 6 and 12 months after the treatment.
- Being tested
- Radio frequency ablation
- Keywords
- Atrial fibrillation, Radiofrequency ablation, Posterior wall isolation, Pulmonary vein 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.
Radio frequency ablationProcedure or surgery
Radio frequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Normal voltage in LA posterior wall - PVI alone | Active comparator | Patients with normal LA posterior wall will be assigned directly to arm 1, receiving PVI alone. Receives: Procedure: Radio frequency ablation |
| Low voltage in LA posterior wall - PVI alone | Active comparator | Patients with low voltage/scar on the LA posterior wall will be randomized to arm 2, receiving PVI alone. Receives: Procedure: Radio frequency ablation |
| Low voltage in LA posterior wall - PVI + PWI | Active comparator | Patients with low voltage/scar on the LA posterior wall will be randomized to arm 3, receiving PVI + PWI. Receives: Procedure: Radio frequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial tachyarrhythmias with duration >30 seconds
Alle episodes of atrial tachyarrhythmia (atrial fibrillation, atrial flutter of atrial tachycardia) with duration >30 seconds recorded 3-months after the ablation procedure will be regarded as recurrence. Blanking period is defined as 3 months.
Measured: 12 months
Secondary outcomes (7)
Complications and adverse events
All periprocedural complications and adverse events during follow-up
Measured: 12 months
Procedure time
Procedure time will be recorded and reported.
Measured: During the procedure
Ablation time
Ablation time will be recorded and reported.
Measured: During the procedure
Fluoroscopy time
Fluoroscopy time will be recorded and reported.
Measured: During the procedure
Quality of life assessment 1
AF Effect On Quality-Of-Life Questionnaire (AFEQT, scores range 0-100, higher scores mean a worse outcome)
Measured: 12 months
Quality of life assessment 2
Assessed by Short Form (36) Heath Survey (SF-36, scores range 0-100, higher scores mean a better outcome)
Measured: 12 months
Frequency of atypical atrial flutter
Incidence of atypical atrial flutter will be reported.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start15 Nov 2023 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (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 Haukeland 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
- Model description
- Prospective, multi-center, open-labeled, partly randomized study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital of North Norway
- Responsible party
- Sponsor
- Investigators
- Jian Chen, MD, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098989
- Sponsor's protocol ID
- 626136
- Acronym
- REPAIR PERS-AF
- Status last verified
- Sep 2023
- First submitted
- 2 Oct 2023
- Last updated
- 25 Oct 2023
- 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 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of REPeat Ablation In Patients With Recurrent PERSistent Atrial Fibrillation: Pulmonary Vein Isolation vs. Adjunct Posterior Wall Isolation (REPAIR PERS-AF Study)
- ClinicalTrials.gov ID
- NCT06098989
- Acronym / sponsor ID
- REPAIR PERS-AF / 626136
- Keywords
- Atrial fibrillation, Radiofrequency ablation, Posterior wall isolation, Pulmonary vein isolation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, University Hospital of North Norway
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 25 Oct 2023 (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.
This study aims to investigate the best strategy for repeat ablation of recurrent persistent atrial fibrillation (AF) after previous persistent AF ablation involving pulmonary vein isolation (PVI) along. Patients with low voltage areas on the posterer wall will be randomized to PVI alone or the posterer wall isoaltion (PWI) in addition to PVI.
Detailed description
This study aims to find a optmal strategy for repeat ablation for recurrent persistent AF after previous persistent AF ablation involving only PVI. PVI is an evident and well documented target for AF ablation. Many other ablation approaches beyond PVI have been reported. PWI is one of the frequently applied methods. However, this appoach has not been studied in randomized clinical trials for recurrent persistent AF after index procedure, thus evidence is demanded for guidance of clinical practice for AF ablation.
The purpose of this study is to clarify this matter by comparing PVI alone strategy with the approach of PVI plus PWI in patients with recurrent persistent AF after index ablation procedure. Since previous clinical studies have shown better outcomes of ablation among patients with normal left atrium (LA) than those with sick LA, ablation strategies in this study will be selected based on voltage mapping of the LA, avoiding unnecessary ablation applications.
The investigators hypothesize that PVI is good enough for patients with normal LA (normal voltage ≥0.5 mV); Among patients with low voltage/scar (voltage < 0.5 mV), PVI plus PWI is superior to PVI alone.
This study is a prospective, multi-center, open-labeled, partly randomized study. After enrollment, patients will receive a voltage mapping of the LA which is routine for all AF ablation procedures. Based on the mapping results, patients will be stratified into two strata, normal voltage (≥ 0.5 mV) and low voltage (< 0.5 mV) in the LA posterior wall. Patients with normal voltage in the LA posterior wall will be directly assigned to arm 1 receiving PVI alone treatment (avoid unnecessary ablation of healthy myocardium). Patients with low voltage will be 1:1 randomized in arms 2 and 3 receiving either PVI alone or PVI + PWI treatment.
- Arm 1: Normal voltage in LA posterior wall - PVI alone
- Arm 2: Low voltage in LA posterior wall - PVI alone
- Arm 3: Low voltage in LA posterior wall - PVI + PWI
Three Norwegian University Hospitals, including Haukeland University Hospital, Bergen, St. Olavs Hospital, Trondheim, and University Hospital of North Norway, Tromsø, will participate in this study. The study is expected to last 3 years, 24 months for enrollment and each patient will be followed for a period of 12 months.
In order to minimize bias, subjects will be randomized next to the LA mapping. Patients will be analyzed according to their initial randomization, that is intention-to-treat, even if they never start the treatment, or discontinue, or cross over the group.
Patents will be followed in out-patient clinic at 3, 6 and 12 months after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, multi-center, open-labeled, partly randomized study.
| Arm | Type | Receives |
|---|---|---|
| Normal voltage in LA posterior wall - PVI alone | Active comparator | Procedure: Radio frequency ablationPatients with normal LA posterior wall will be assigned directly to arm 1, receiving PVI alone. |
| Low voltage in LA posterior wall - PVI alone | Active comparator | Procedure: Radio frequency ablationPatients with low voltage/scar on the LA posterior wall will be randomized to arm 2, receiving PVI alone. |
| Low voltage in LA posterior wall - PVI + PWI | Active comparator | Procedure: Radio frequency ablationPatients with low voltage/scar on the LA posterior wall will be randomized to arm 3, receiving PVI + PWI. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Symptomatic patients with persistent AF and indication for repeat ablation
- procedure.
- Patients with recurrent persistent AF (with a duration <3 year, at least one episode longer than 7 days during the last 6 months and have been electrically cardioverted at least once during the last 12 months) after previous catheter ablation.
- Patients with up to two previous catheter ablations for AF are included if the procedures only involved PVI. Previous PVI procedure(s) with both cryoablation and radiofrequency ablation are accepted.
- Patients have taken at least one antiarrhythmic drug.
Key exclusion criteria (16 listed)
- Patients with >2 ablation procedures in the LA for AF or atrial flutter
- Previous ablation procedures for AF involving ablation strategies beyond PVI
- Duration of persistent AF >3 years
- Presence of atrial flutter or atrial tachycardia
- Presence of an intracavitary thrombus
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 |
|---|---|---|
| Radio frequency ablationRadio frequency ablation | Procedure or surgery | Low voltage in LA posterior wall - PVI + PWI, Low voltage in LA posterior wall - PVI alone, Normal voltage in LA posterior wall - PVI alone |
Primary outcome
Atrial tachyarrhythmias with duration >30 seconds
Time frame: 12 months
Alle episodes of atrial tachyarrhythmia (atrial fibrillation, atrial flutter of atrial tachycardia) with duration >30 seconds recorded 3-months after the ablation procedure will be regarded as recurrence. Blanking period is defined as 3 months.
7 secondary outcomes
Complications and adverse events
Time frame: 12 months
Procedure time
Time frame: During the procedure
Ablation time
Time frame: During the procedure
Fluoroscopy time
Time frame: During the procedure
Quality of life assessment 1
Time frame: 12 months
Quality of life assessment 2
Time frame: 12 months
Frequency of atypical atrial flutter
Time frame: 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 25 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Jian Chen, MD, PhD principal investigator
Haukeland University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Radio frequency ablation in people with Atrial Fibrillation, Persistent and Atrial Fibrillation Recurrent, run by Haukeland University Hospital.
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 8 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: opening soon, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Kristian Wollner, MD (92229412 ext. +47, wollnerkristian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial tachyarrhythmias with duration >30 seconds (time frame: 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 25 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.