MedTrace Logo

Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)

NCT06698159 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2024-11-20

No results posted yet for this study

Summary

The WIDER PVI study is a multicentre randomized clinical trial to compare the efficacy of antral versus extended antral PVI in patients with paroxysmal or persistent AF undergoing this procedure using a cryoablation balloon capable of 28 mm diameter (antral isolation) or 31 mm diameter (extended antral isolation) applications. The aim is to evaluate an objective of superiority of the extended antral isolation strategy versus antral isolation in the recurrence of atrial tachyarrhythmias at 1-year follow-up, both in episodes of \>30 seconds duration and in overall arrhythmic load.

Conditions

Interventions

DEVICE

Cryoablation with cryoballoon 28 mm

Pulmonary vein isolation using 28 mm balloon cryoablation

DEVICE

Cryoablation with cryoballoon 31 mm

Pulmonary vein isolation using 31 mm balloon cryoablation

Sponsors & Collaborators

  • Hospital Universitario 12 de Octubre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-05-01
Completion
2027-06-30

Countries

  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT06698159 on ClinicalTrials.gov