NCT03388658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,003

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

8.5 years

First QC Date

October 20, 2017

Last Update Submit

December 22, 2017

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Cryoballoon; Ablation;

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Post procedure morbidities

    in a 8-year follow-up period

  • Cryoballoon 1 versus cryoballoon 2

    in a 1200-day follow-up period

  • Clinical characteristics and predictive factors for success / complications

    in a 8-year follow-up period

  • Continuation of medical treatment post ablation

    in a 1200-day follow-up period

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who have benefited from atrial fibrillation cryoablation in the grenoble University Hospital

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversityHospitalGrenoble

Grenoble, 38043, France

Location

Related Publications (5)

  • 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.

    PMID: 25186456BACKGROUND

  • 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.

    PMID: 27422848BACKGROUND

  • 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.

    PMID: 27683062BACKGROUND

  • 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.

    PMID: 27381589BACKGROUND

  • 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.

    PMID: 25995389BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sandrine VENIER, Dr

    UniversityHospital Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2017

First Posted

January 3, 2018

Study Start

November 1, 2007

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

January 3, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)