Safety and Efficacy of Cryoballoon Pulmonary Vein Isolation : a Single Center Registry (Gr-CryoFS)

December 22, 2017 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

1003

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • UniversityHospitalGrenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
in a 8-year follow-up period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
in a 8-year follow-up period
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.
in a 1200-day follow-up period
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
in a 8-year follow-up period
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
in a 1200-day follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Sandrine VENIER, Dr, UniversityHospital Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2007

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

December 22, 2017

First Posted (ACTUAL)

January 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 22, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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