FREEZE Cohort Study

Arrhythmia Clinical Trial

Official title:

FREEZE Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360008
• Other study ID #: FREEZE
• Status: Completed
• Start date: April 2011
• Est. completion date: April 2017

Study information

• Verified date: September 2017
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4071
• Est. completion date: April 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Arrhythmia

Locations

Country	Name	City	State
Austria	Allgemeines KH Linz	Linz
Germany	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	Universitätsklinikum Bonn (Med. Klinik und Poliklinik II)	Bonn
Germany	Klinikum Coburg	Coburg
Germany	Praxisklinik Herz und Gefäße	Dresden
Germany	Elisabeth-Krankenhaus Essen; Klinik für Kardiologie und Angiologie	Essen
Germany	Cardioangiologisches Centrum Bethanien - CCB	Frankfurt
Germany	Städt. Klinikum Frankfurt Höchst	Frankfurt
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Universitäres Herzzentrum	Hamburg
Germany	Universitäres Herzzentrum Eppendorf	Hamburg
Germany	Klinikum Siloah	Hannover
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Städt. Klinikum Hildesheim	Hildesheim
Germany	Klinikum Ingolstadt	Ingolstadt
Germany	Westpfalz-Klinikum GmbH	Kaiserslautern
Germany	St. Vinzenz Hospital Köln-Nippes	Köln
Germany	Universitätsklinik Schleswig-Holstein Campus Lübeck	Lübeck
Germany	Universitätsmedizin Mainz	Mainz
Germany	Isar Herzzentrum München	München
Germany	Krankenhaus München Bogenhausen	München
Germany	Universitätsklinikum Münster	Münster
Germany	Klinikum Traunstein	Traunstein
Germany	Schwarzwald-Baar-Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen
Greece	Evangelismos General Hospital	Athens
South Africa	Sunninghill Hospital	Johannesburg
South Africa	Panorama Medi-Clinic	Panorama
South Africa	Milpark Hospital	Parktown West
Spain	University Hospital Virgen de la Arrixaca	El Palmar - Murcia
United States	Mission Hospital, Inc.	Asheville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung	Medtronic

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Greece,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up		Admission to hospital until 12 months thereafter
Secondary	Comparison of complication rates (any complications and major complications) at 12 months follow-up		Admission to hospital until 12 months thereafter
Secondary	Specific complication aspects with respect to phrenic nerve palsy and PV stenosis		Admission to Hospital until 12 months thereafter
Secondary	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
Secondary	Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI		Admission to Hospital until 12 months thereafter
Secondary	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

External Links

•   EP Europace, euz155: Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation