FREEZE Cohort Study

Completed

• Conditions: Arrhythmia

• Registration Number: NCT01360008
• Lead Sponsor: Stiftung Institut fuer Herzinfarktforschung

Brief Summary

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.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-25
• Primary Completion: 2016-01
• Study Completion: 2017-04
• Status Verified: 2017-09
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4071

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up	Admission to hospital until 12 months thereafter

Secondary Outcome Measures

Name	Time	Method
Specific complication aspects with respect to phrenic nerve palsy and PV stenosis	Admission to Hospital until 12 months thereafter
Comparison of complication rates (any complications and major complications) at 12 months follow-up	Admission to hospital until 12 months thereafter
Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI	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	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	Admission to Hospital until 12 months thereafter

Trial Locations

Locations (37)

Mission Hospital, Inc.; 🇺🇸 Asheville, North Carolina, United States

Allgemeines KH Linz; 🇦🇹 Linz, Austria

Klinikum Aschaffenburg; 🇩🇪 Aschaffenburg, Germany

Herz-Zentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Germany

Herz- und Gefäßklinik Bad Neustadt; Klinik für Kardiologie II; 🇩🇪 Bad Neustadt, Germany

Herz- und Diabeteszentrum; 🇩🇪 Bad Oeynhausen, Germany

Deutsches Herzzentrum Berlin (Kardiologie); 🇩🇪 Berlin, Germany

Vivantes Klinikum Am Urban; 🇩🇪 Berlin, Germany

Klinikum Bielelfeld - Klinik für Kardiologie und internistische Intensivmedizin; 🇩🇪 Bielefeld, Germany

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