Re-ablation of Persistent Atrial Fibrillation

NCT ID: NCT06845085

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2032-10-31

Brief 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, 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.

Conditions

Atrial Fibrillation, Persistent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

vein re-isolation plus VOM ablation and 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

Group Type: EXPERIMENTAL

Intervention

Intervention Type: PROCEDURE

pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line

vein re-isolation

pulmonary vein re-isolation

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: PROCEDURE

pulmonary vein re-isolation

Interventions

Intervention

pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line

Intervention Type: PROCEDURE

Control

pulmonary vein re-isolation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Lukac

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Cardiology, Aarhus University Hospital

Århus N, Danmark, Denmark

Department of Cardiology, Leiden University Medical Center

Leiden, , Netherlands

Department of Cardiology, Karolinska University Hospital, Stockholm

Stockholm, , Sweden

Countries

Denmark; Netherlands; Sweden

Central Contacts

Peter Lukac, MD, PhD

Role: CONTACT

peteluka@rm.dk

+45 40293641

Mads Brix Kronborg, MD, PhD, DMSc

Role: CONTACT

madskron@rm.dk

+ 45 29896776

Facility Contacts

Peter Lukac, MD, PhD

Role: primary

peteluka@rm.dk

+45 40293641

Mads Brix Lukac, MD, PhD, DMSc

Role: backup

madskron@rm.dk

+45 29896776

Sebastiaan Piers, MD, PhD

Role: primary

S.R.D.Piers@lumc.nl

+31 71 526 20 20

Finn Åkerström, MD, PhD

Role: primary

finn.akerstrom@regionstockholm.se

+46 734646045

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

1-10-72-153-24

Identifier Type: -

Identifier Source: org_study_id