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

NCT04165642 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 82

Last updated 2023-10-02

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Principal Investigators

  • Carlo Pappone, MD, PhD · IRCCS Policlinico S. Donato

Eligibility

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

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2023-06-22
Completion
2023-07-05

Countries

  • Italy

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 NCT04165642 on ClinicalTrials.gov