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Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure

NCT05264831 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2024-04-24

No results posted yet for this study

Summary

This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation.

All included patients will undergo an electric cardioversion, then:

* Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients.
* Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures:

* PVI procedure alone
* PVI procedure combined with substrate modulation

Conditions

  • Persistent Atrial Fibrillation

Interventions

PROCEDURE

Pulmonary Vein Isolation (PVI) alone

PVI procedures correspond to point-by-point 50W AI-guided RF applications (400 posterior LA wall, and 550 elsewhere). The PVI will be validated by the absence of any activity recorded inside the PV encirclement by a multipolar catheter (either a Lasso catheter or a Pentaray catheter) (entrance block) and by the non-capture of the LA despite pacing maneuvers from inside the encirclement (exit block). The bidirectional block will be validated again after a 15-minutes waiting period.

PROCEDURE

PVI procedure associated with substrate modulation

PVI procedure associated with substrate modulation

Sponsors & Collaborators

  • Elsan

    lead OTHER

Principal Investigators

  • Augustin Bortone, MD · Elsan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2025-04-01
Completion
2027-10-01

Countries

  • France

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 NCT05264831 on ClinicalTrials.gov