Safety and Efficacy of Cryoballoon Pulmonary Vein Isolation : a Single Center Registry
NCT ID: NCT03388658
Last Updated: 2018-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1003 participants
OBSERVATIONAL
2007-11-30
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation
NCT01521988
Cryoballoon Atrial Fibrillation Ablation Registry
NCT03040037
Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
NCT01448265
Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation
NCT01645917
A Prospective Study of Medical Therapy Against Cryoballoon Ablation in Symptomatic Recent Onset Persistent AF
NCT02389218
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 who refused to sign informed consent for the procedure of ablation
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sandrine VENIER, Dr
Role: PRINCIPAL_INVESTIGATOR
UniversityHospital Grenoble
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UniversityHospitalGrenoble
Grenoble, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne 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. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
38RC17.216
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.