Safety and Efficacy of Cryoballoon Pulmonary Vein Isolation : a Single Center Registry (Gr-CryoFS)
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|ClinicalTrials.gov Identifier: NCT03388658|
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||1003 participants|
|Official Title:||Safety and Efficacy of Cryoballoon Pulmonary Vein Isolation : a Single Center Registry|
|Actual Study Start Date :||November 2007|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2017|
- Long term efficacy of cryoballoon ablation for atrial fibrillation (AF) [ Time Frame: 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)
- Post procedure morbidities [ Time Frame: 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.
- Cryoballoon 1 versus cryoballoon 2 [ Time Frame: 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 [ Time Frame: 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
- Continuation of medical treatment post ablation [ Time Frame: in a 1200-day follow-up period ]Continuation of anti-coagulant or anti-arrhythmic treatments beyond 3 months after the procedure will be collected
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388658
|Grenoble, France, 38043|
|Principal Investigator:||Sandrine VENIER, Dr||UniversityHospital Grenoble|