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Completed

NCT Number: NCT03388658

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UniversityHospitalGrenoble

Grenoble, 38043, France

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: Gr-CryoFS

Important dates

Study start
2007
Primary completion
2016
Study completion
2017
First posted
Jan 3, 2018
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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