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

Atrial Fibrillation Clinical Trial

— Gr-CryoFS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388658
• Other study ID #: 38RC17.216
• Status: Completed
• Phase: N/A
• First received: October 20, 2017
• Last updated: December 22, 2017
• Start date: November 2007
• Est. completion date: May 2017

Study information

• Verified date: December 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: May 2017
• Est. primary completion date: May 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

Cardoso R, Mendirichaga R, Fernandes G, Healy C, Lambrakos LK, Viles-Gonzalez JF, Goldberger JJ, Mitrani RD. Cryoballoon versus Radiofrequency Catheter Ablation in Atrial Fibrillation: A Meta-Analysis. J Cardiovasc Electrophysiol. 2016 Oct;27(10):1151-1159. doi: 10.1111/jce.13047. Epub 2016 Aug 16. Review. — View Citation

Jiang J, Li J, Zhong G, Jiang J. Efficacy and safety of the second-generation cryoballoons versus radiofrequency ablation for the treatment of paroxysmal atrial fibrillation: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2017 Jan;48(1):69-79. doi: 10.1007/s10840-016-0191-9. Epub 2016 Sep 28. Review. — View Citation

Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H, Khoueiry Z, Cardin C, Combes N, Combes S, Boveda S, Albenque JP. Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace. 2015 Feb;17(2):225-31. doi: 10.1093/europace/euu215. Epub 2014 Sep 3. — View Citation

Kuck KH, Fürnkranz A, Chun KR, Metzner A, Ouyang F, Schlüter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kühne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. Epub 2016 Jul 5. — View Citation

Lemes C, Wissner E, Lin T, Mathew S, Deiss S, Rillig A, Heeger C, Wohlmuth P, Reissmann B, Tilz R, Ouyang F, Kuck KH, Metzner A. One-year clinical outcome after pulmonary vein isolation in persistent atrial fibrillation using the second-generation 28 mm cryoballoon: a retrospective analysis. Europace. 2016 Feb;18(2):201-5. doi: 10.1093/europace/euv092. Epub 2015 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term efficacy of cryoballoon ablation for atrial fibrillation (AF)	Absence of recurrence (recurrence was defined as symptomatic or documented arrhythmia episode of>30 seconds excluding a 3-month blanking period)	in a 8-year follow-up period
Secondary	Post procedure morbidities	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.	in a 8-year follow-up period
Secondary	Cryoballoon 1 versus cryoballoon 2	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.	in a 1200-day follow-up period
Secondary	Clinical characteristics and predictive factors for success / complications	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	in a 8-year follow-up period
Secondary	Continuation of medical treatment post ablation	Continuation of anti-coagulant or anti-arrhythmic treatments beyond 3 months after the procedure will be collected	in a 1200-day follow-up period