NCT04165642

Single-Laser PVI: Single-encirclement Laserballoon Ablation for Pulmonary Veins Isolation

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 82 (actual)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

Summary

To assess the efficacy of laser balloon ablation of atrial fibrillation (AF) without verification of electrical isolation of pulmonary veins using implantable loop recorder. This is a prospective and single-center study. A targeted number of 82 patients suffering from paroxysmal or persistent AF, indicated to undergo catheter ablation will be included. The study will consist of: i) patient enrolment, ii) treatment phase, and iii) 1-year follow-up phase. The duration of the study is expected to be 24 months, from first patient enrolment to last patient follow up.

Detailed description

This is a prospective and single-center study. A targeted number of 82 patients suffering from paroxysmal or persistent AF, indicated to undergo catheter ablation will be included. The study will consist of: i) patient enrolment, ii) treatment phase, and iii) 1-year follow-up phase. The duration of the study is expected to be 24 months, from first patient enrolment to last patient follow up. In a recent meta-analysis including 1188 patients, free from arrhythmic recurrences at 12 months after a single ablative procedure with a laser balloon and without continuous monitoring with ILR was 74%1. Assuming that the approach without post-ablative verification of pulmonary vein isolation and continuous monitoring with ILR can lead to a 60% success rate at 12 months, 80 patients are required to have an 80% probability to observe a level of 2-code significance of 0.05 in an exponential model with the log rank test. With an estimated loss of data (patients lost to follow-up, protocol deviations and incomplete data) of 5%, the total number of patients to be enrolled is 82. Subject screening and enrolment will be carried out for approximately 12 months. The study will continue up to 12 months after last patient enrolment, dependent on the rate of enrolment and the regulatory timeline (as applicable).

Conditions

• Assessment of Safety of Laser Balloon Ablation
• Assessment of Procedural Times of Laser Ballon Ablation

Interventions

Type	Name	Description
OTHER	Laser ballon ablation for Pulmonary vein isolation	The patients indicated to AF ablation procedure will be treated with laser balloon ablation without verification of electrical isolation of pulmonary veins using implantable loop recorder and/or Holter monitoring

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-06-22
• Completion: 2023-07-05
• First posted: 2019-11-18
• Last updated: 2023-10-02

Locations

1 site across 1 country: Italy