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VEin of MArshall Ethanolization Vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF

NCT06383975 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-10-09

No results posted yet for this study

Summary

The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation (irregular and often very rapid heart rhythm). An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat. In this trial researchers will compare a new technique, which uses tiny electric shocks to make the scars, to the standard technique, which uses heat.

The main question the trial aims to answer is:

• Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure?

Participants will:

* Undergo an ablation with either the new or the standard technique
* Visit the hospital 1, 3, 6, 9 and 12 months after the procedure for a check-up
* Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6, 9 and 12 month visit
* Record their heart rhythm at home every week
* Complete a questionnaire 3, 6, 9 and 12 months after the procedure

Conditions

  • Persistent Atrial Fibrillation

Interventions

PROCEDURE

Pulsed field ablation with posterior wall isolation

Extended pulmonary vein isolation including posterior wall isolation using pulsed field ablation

PROCEDURE

Radiofrequency ablation and vein of Marshall ethanolization

Radiofrequency pulmonary vein re-isolation (when necessary), vein of Marshall ethanol infusion with roof and mitral lines

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Sebastien Knecht

    lead OTHER

Principal Investigators

  • Sébastien Knecht, MD, PhD · AZ Sint-Jan Brugge AV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Belgium

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 NCT06383975 on ClinicalTrials.gov