NCT06845085

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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
78mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Mar 2025Oct 2032

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2032

Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

4.6 years

First QC Date

February 20, 2025

Last Update Submit

February 26, 2025

Conditions

Atrial Fibrillation, Persistent

Keywords

Persistent atrial fibrillationRadiofrequency ablationPulsed field ablationVein of Marshall alcohol ablationCavotricuspid isthmus lineMitral isthmus lineDome linePulmonary vein re-isolation

Outcome Measures

Primary Outcomes (1)

  • 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

    between baseline and 12 months

Secondary Outcomes (7)

  • Freedom from documented atrial arrhythmia

    12, 24 and 60 months

  • Freedom from documented persistent atrial arrhythmia

    at 12 and 24 months and 5 years

  • Freedom from direct-current cardioverted atrial arrhythmia

    at 12 and 24 months and 5 years

  • Number of direct current-cardioversions and sustained atrial arrhythmia episodes

    at 12 and 24 months and 5 years

  • Freedom from accepted chronic atrial fibrillation

    at 12 and 24 months and 5 years.

  • +2 more secondary outcomes

Study Arms (2)

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

Procedure: Intervention

vein re-isolation

ACTIVE COMPARATOR

pulmonary vein re-isolation

Procedure: Control

Interventions

InterventionPROCEDURE

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 plus VOM ablation and block of mitral and tricuspid isthmuses and dome line
ControlPROCEDURE

pulmonary vein re-isolation

vein re-isolation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Cardiology, Aarhus University Hospital

Århus N, Danmark, 8250, Denmark

Location

Department of Cardiology, Leiden University Medical Center

Leiden, 2333, Netherlands

Location

Department of Cardiology, Karolinska University Hospital, Stockholm

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Methods

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Peter Lukac, MD, PhD

CONTACT

+45 40293641peteluka@rm.dk

Mads Brix Kronborg, MD, PhD, DMSc

CONTACT

+ 45 29896776madskron@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2032

Last Updated

February 28, 2025

Record last verified: 2025-02

Locations

NL(1)SE(1)DK(1)