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FREEZE Cohort Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Stiftung Institut fuer Herzinfarktforschung
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01360008
First received: May 13, 2011
Last updated: January 14, 2014
Last verified: July 2013

May 13, 2011
January 14, 2014
April 2011
May 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01360008 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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FREEZE Cohort Study
FREEZE Cohort Study

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with AF ablation targeting

Arrhythmia
Not Provided
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Straube F, Dorwarth U, Vogt J, Kuniss M, Heinz Kuck K, Tebbenjohanns J, Garcia Alberola A, Chun KR, Souza JJ, Ouarrak T, Senges J, Brachmann J, Lewalter T, Hoffmann E. Differences of two cryoballoon generations: insights from the prospective multicentre, multinational FREEZE Cohort Substudy. Europace. 2014 Oct;16(10):1434-42. doi: 10.1093/europace/euu162. Epub 2014 Jul 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
Not Provided
May 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States,   Austria,   Germany,   Greece,   South Africa,   Spain
 
NCT01360008
FREEZE
Yes
Stiftung Institut fuer Herzinfarktforschung
Stiftung Institut fuer Herzinfarktforschung
Medtronic
Principal Investigator: Ellen Hoffmann, MD Klinikum Bogenhausen, München
Stiftung Institut fuer Herzinfarktforschung
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP