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Re-ablation of Persistent Atrial Fibrillation

NCT06845085 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-02-28

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation, Persistent

Interventions

PROCEDURE

Intervention

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

PROCEDURE

Control

pulmonary vein re-isolation

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2029-10-31
Completion
2032-10-31

Countries

  • Denmark
  • Netherlands
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06845085 on ClinicalTrials.gov