FREEZE Cohort Study

June 25, 2019 updated by: Stiftung Institut fuer Herzinfarktforschung
Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation will be investigated in a cohort study design in experienced electrophysiologic (EP) centers analyzing propensity-matched cohorts.

Study Overview

Status

Completed

Conditions

Detailed Description

Prior to participation in the cohort-study each EP center had to perform a minimum of 50 RF or 50 cryoballoon approaches. To insure the consecutiveness of recruitment, participating centers have to announce the intention to ablate the patient prior to the procedure to the coordinating center in Ludwigshafen. After inclusion of 500 patients with well accepted criteria for AF ablation undergoing cryoballoon pulmonary vein isolation (PVI) in experienced german EP centers inclusion of patients will be extended to european centers. A total of 4.000 patients will be included in the cohort-study, 2.000 in both the cryoballoon and the RF arm.

Study Type

Observational

Enrollment (Actual)

4071

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

  • Austria
      • Linz, Austria, 4020
        • Allgemeines KH Linz
  • Germany
      • Aschaffenburg, Germany, 63739
        • Klinikum Aschaffenburg
      • Bad Krozingen, Germany
        • Herz-Zentrum Bad Krozingen
      • Bad Nauheim, Germany
        • Kerckhoff-klinik
      • Bad Neustadt, Germany, 97616
        • Herz- und Gefäßklinik Bad Neustadt; Klinik für Kardiologie II
      • Bad Oeynhausen, Germany
        • Herz- und Diabeteszentrum
      • Berlin, Germany, 13353
        • Deutsches Herzzentrum Berlin (Kardiologie)
      • Berlin, Germany
        • Vivantes Klinikum Am Urban
      • Bielefeld, Germany, 33604
        • Klinikum Bielelfeld - Klinik für Kardiologie und internistische Intensivmedizin
      • Bonn, Germany, 53105
        • Universitätsklinikum Bonn (Med. Klinik und Poliklinik II)
      • Coburg, Germany
        • Klinikum Coburg
      • Dresden, Germany
        • Praxisklinik Herz und Gefäße
      • Essen, Germany, 45138
        • Elisabeth-Krankenhaus Essen; Klinik für Kardiologie und Angiologie
      • Frankfurt, Germany, 65929
        • Städt. Klinikum Frankfurt Höchst
      • Frankfurt, Germany
        • Cardioangiologisches Centrum Bethanien - CCB
      • Hamburg, Germany, 20246
        • Universitäres Herzzentrum Eppendorf
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Hamburg, Germany
        • Universitäres Herzzentrum
      • Hannover, Germany, 30449
        • Klinikum Siloah
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Hildesheim, Germany
        • Städt. Klinikum Hildesheim
      • Ingolstadt, Germany, 85049
        • Klinikum Ingolstadt
      • Kaiserslautern, Germany
        • Westpfalz-Klinikum GmbH
      • Köln, Germany, 50733
        • St. Vinzenz Hospital Köln-Nippes
      • Lübeck, Germany, 23538
        • Universitätsklinik Schleswig-Holstein Campus Lübeck
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz
      • München, Germany
        • Isar Herzzentrum München
      • München, Germany
        • Krankenhaus München Bogenhausen
      • Münster, Germany
        • Universitätsklinikum Münster
      • Traunstein, Germany, 83278
        • Klinikum Traunstein
      • Villingen-Schwenningen, Germany, 78052
        • Schwarzwald-Baar-Klinikum Villingen-Schwenningen GmbH
  • Greece
      • Athens, Greece, 106 76
        • Evangelismos General Hospital
  • South Africa
      • Johannesburg, South Africa, 2196
        • Sunninghill Hospital
      • Panorama, South Africa, 7500
        • Panorama Medi-Clinic
      • Parktown West, South Africa, 2193
        • Milpark Hospital
  • Spain
      • El Palmar - Murcia, Spain, 30120
        • University Hospital Virgen de la Arrixaca
  • United States
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Mission Hospital, Inc.

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with AF ablation targeting

Description

Inclusion Criteria:

  • Documented paroxysmal AF (2 episodes of PAF within the last 3 months) or Persistent AF (lasting < 1 year)
  • First ablation of AF
  • Age ≥18 years
  • Documented inefficacy of at least 1 AAD not including β-blockers
  • Written informed consent

Exclusion Criteria:

  • Longstanding persistent AF lasting > 1 year
  • Acute coronary syndrome (ACS)
  • Heart failure NYHA IV
  • Thrombocytosis, thrombocytopenia
  • Any condition contraindicating chronic anticoagulation
  • Stroke or TIA within 6 months prior to ablation
  • Uncontrolled hyperthyroidism
  • Pregnancy
  • Life expectancy < 1 year

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cryo ablation
Patients with first Ablation of atrial fibrillation treated by cryo ablation
RF ablation
Patients with first Ablation of atrial fibrillation treated by Radio frequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up
Time Frame: Admission to hospital until 12 months thereafter
Admission to hospital until 12 months thereafter

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of complication rates (any complications and major complications) at 12 months follow-up
Time Frame: Admission to hospital until 12 months thereafter
Admission to hospital until 12 months thereafter
Specific complication aspects with respect to phrenic nerve palsy and PV stenosis
Time Frame: Admission to Hospital until 12 months thereafter
Admission to Hospital until 12 months thereafter
Efficacy (AF recurrency rates), safety (complication rates), and procedural parameters in cryoballoon or RF ablation as means for assessing advantages of preprocedural CT or MRI scan performing 3 D anatomy of the left atrium and pulmonary veins
Time Frame: Admission to Hospital until 12 months thereafter
Admission to Hospital until 12 months thereafter
Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI
Time Frame: Admission to Hospital until 12 months thereafter
Admission to Hospital until 12 months thereafter
Real-time ECG-monitoring of PV-isolation during freezing: Does the microcircular mapping catheter add significant benefit to the cryoballoon procedure
Time Frame: Admission to Hospital until 12 months thereafter
Admission to Hospital until 12 months thereafter

Collaborators and Investigators

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

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Collaborators

Medtronic

Investigators

  • Principal Investigator: Ellen Hoffmann, MD, Klinikum Bogenhausen, München

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

Helpful Links

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

April 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

May 23, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FREEZE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

De-identified patient data will be published after end of follow up period

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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