Safety and Efficacy of Cryoballoon Pulmonary Vein Isolation : a Single Center Registry (Gr-CryoFS)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Other

Identifiers

NCT03388658

38RC17.216

Details and patient eligibility

About

The aim of this study was to assess the long-term success rates of pulmonary vein isolation using first and second generation cryoballoons in patients with paroxysmal and persistent atrial fibrillation.

Full description

The success of ablation is determined by the absence of recurrence of atrial fibrillation in the short term beyond 3 months, medium and long term on regular clinical follow-up and ECG holters. The patient cohort followed since 2007 allows a very long-term follow-up of patients who have benefited from atrial fibrillation cryoablation.

Isolation of the pulmonary veins by cryoballoon (IVP) has emerged as an alternative to radiofrequency in the treatment of drug resistant atrial fibrillation (AF). (1) The potential benefits of cryoablation include shorter procedure times, decreased fluoroscopy time, shorter hospital duration, a different rate and type of complications compared to radio frequency offers potential benefits, including Including shorter procedure times, a decrease in the length of hospital stay 1 and a reduction in fluoroscopic time. (2) Effectiveness on a one year follow-up in cryoablation for AF is comparable to that of radiofrequency ablation in a prospective, randomized study with a lower major complication rate (3,4). The number of subjects is limited and most retrospective studies on cryoablation have a limited number of patients or an average follow-up not exceeding one year.

Study of the data and results of the procedures of ablation of AF by cryoablation and long-term follow-up of the patients of the CHU of Grenoble.

Regular monocentric cohort study based on collected data To identify the success rate of cryoablation ablation in paroxysmal and persistent AF

Enrollment: 1,003 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with an indication for ablation of atrial fibrillation at the CHU of Grenoble since the use of this technique (November 2007) until November 2016:
• Paroxysmal atrial fibrillation resistant to antiarrhythmic treatment.
• Persistent atrial fibrillation.
• Patients ≥18 years
• Patients with discernment who signed consent for information on the ablation procedure before surgery.

Exclusion criteria

• patient less than 18 years old
• patient who refused to sign informed consent for the procedure of ablation