FREEZE Cohort Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Stiftung Institut fuer Herzinfarktforschung.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Stiftung Institut fuer Herzinfarktforschung
Collaborator:
Medtronic
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01360008
First received: May 13, 2011
Last updated: May 23, 2011
Last verified: May 2011
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Purpose
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. 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.
| Condition |
|---|
|
Arrhythmia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | FREEZE Cohort Study |
Resource links provided by NLM:
Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:
Primary Outcome Measures:
- AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up [ Time Frame: Admission to hospital until 12 months thereafter ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Comparison of complication rates (any complications and major complications) at 12 months follow-up [ Time Frame: Admission to hospital until 12 months thereafter ] [ Designated as safety issue: Yes ]
- Specific complication aspects with respect to phrenic nerve palsy and PV stenosis [ Time Frame: Admission to Hospital until 12 months thereafter ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI [ Time Frame: Admission to Hospital until 12 months thereafter ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4000 |
| Study Start Date: | April 2011 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with AF ablation targeting
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360008
Locations
| Germany | |
| Herz-Zentrum Bad Krozingen | Recruiting |
| Bad Krozingen, Germany | |
| Contact: Thomas Arentz, MD thomas.arentz@herzzentrum.de | |
| Kerckhoff-Klinik | Recruiting |
| Bad Nauheim, Germany | |
| Contact: Heinz-Friedrich Pitschner, MD h.pitschner@kerckhoff-klinik.de | |
| Herz- und Diabeteszentrum | Recruiting |
| Bad Oeynhausen, Germany | |
| Contact: Jürgen Vogt, MD jvogt@hdz-nrw.de | |
| Vivantes Klinikum Am Urban | Recruiting |
| Berlin, Germany | |
| Contact: Dietrich Andresen, MD Dietrich.Andresen@vivantes.de | |
| Klinikum Coburg | Recruiting |
| Coburg, Germany | |
| Contact: Johannes Brachmann, MD johannes.brachmann@klinikum-coburg.de | |
| Praxisklinik Herz und Gefäße | Recruiting |
| Dresden, Germany | |
| Contact: Stefan G. Spitzer, MD prof.spitzer@praxisklinik-dresden.de | |
| Cardioangiologisches Centrum Bethanien - CCB | Recruiting |
| Frankfurt, Germany | |
| Contact: K.R. Julian Chun, MD j.chun@ccb.de | |
| Universitäres Herzzentrum | Recruiting |
| Hamburg, Germany | |
| Contact: Stephan Willems, MD willems@uke.uni-hamburg.de | |
| Asklepios Klinik St. Georg | Recruiting |
| Hamburg, Germany | |
| Contact: Karl-Heinz Kuck, MD k.kuck@asklepios.com | |
| Städt. Klinikum Hildesheim | Recruiting |
| Hildesheim, Germany | |
| Contact: Johannes Brachmann, MD j.tebbenjohanns@stk-hildesheim.de | |
| Westpfalz-Klinikum GmbH | Recruiting |
| Kaiserslautern, Germany | |
| Contact: Burghard Schumacher, MD bschumacher@westpfalz-klinikum.de | |
| Isar Herzzentrum München | Recruiting |
| München, Germany | |
| Contact: Thorsten Lewalter, MD Thorsten.Lewalter@isarkliniken.de | |
| Krankenhaus München Bogenhausen | Recruiting |
| München, Germany | |
| Contact: Ellen Hoffmann, MD ellen.hoffmann@klinikum-muenchen.de | |
| Universitätsklinikum Münster | Recruiting |
| Münster, Germany | |
| Contact: Lars Eckardt, MD l.eckardt@uni-muenster.de | |
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Medtronic
Investigators
| Principal Investigator: | Ellen Hoffmann, MD | Klinikum Bogenhausen, München |
More Information
No publications provided
| Responsible Party: | Prof. Dr. med. Jochen Senges, Stiftung Institut für Herzinfarktforschung Ludwigshafen |
| ClinicalTrials.gov Identifier: | NCT01360008 History of Changes |
| Other Study ID Numbers: | FREEZE |
| Study First Received: | May 13, 2011 |
| Last Updated: | May 23, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
|
Cardiac arrhythmia Catheter ablation Cohort Study cryoballoon radiofrequency |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013