Safety and Efficacy of Cryoballoon Pulmonary Vein Isolation : a Single Center Registry

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT03388658
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2016-05
• Study Completion: 2017-05
• Study First Submitted: 2017-10-20
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-22
• Last Update Submitted: 2017-12-22
• Study First Posted: 2018-01-03
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1003

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long term efficacy of cryoballoon ablation for atrial fibrillation (AF)	in a 8-year follow-up period	Absence of recurrence (recurrence was defined as symptomatic or documented arrhythmia episode of\>30 seconds excluding a 3-month blanking period)

Secondary Outcome Measures

Name	Time	Method
Post procedure morbidities	in a 8-year follow-up period	The secondary outcomes include adverse events related to the procedure: death from any causes, atrial-oesophageal fistula, pericardial tamponade, neurological complication, phrenic nerve palsy, hematoma and vascular complications.
Continuation of medical treatment post ablation	in a 1200-day follow-up period	Continuation of anti-coagulant or anti-arrhythmic treatments beyond 3 months after the procedure will be collected
Cryoballoon 1 versus cryoballoon 2	in a 1200-day follow-up period	Comparison of acute and long term efficacy in of the first versus second generation cryoballoon; -The success rate is evaluated at clinical follow-up and Holter, the efficacy of treatment is evaluated by per-ablation data. Total procedure times, catheter time in the left atrium, fluoroscopy time, cryoablation time are collected during the procedure and will be retrospectively analyzed with patient records and ablation records. The comparison will be made on the patient group having been treated with the new techniques and in particular the second generation balloon and those having been treated with the first generation balloon.
Clinical characteristics and predictive factors for success / complications	in a 8-year follow-up period	The clinical characteristics collected prospectively on the basis since 2007 will be analyzed retrospectively to evaluate one or more factors predicting success or complications of the procedure

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 Grenoble, France