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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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 Type : Observational
Actual Enrollment : 1003 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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

  4. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
patients who have benefited from atrial fibrillation cryoablation in the grenoble University Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388658


Locations
France
UniversityHospitalGrenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Sandrine VENIER, Dr UniversityHospital Grenoble

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03388658     History of Changes
Other Study ID Numbers: 38RC17.216
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:
Atrial Fibrillation; Cryoballoon; Ablation;

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes