Clinical trial NCT01360008: FREEZE Cohort Study
Official title: FREEZE Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmia
Keywords: Cardiac arrhythmia
Catheter ablation
Cohort Study
cryoballoon
radiofrequency
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2011-05-25
Enrollment: 4071
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AF ablation targeting

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.

Eligibility 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

Primary outcomes:
measure: AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up
timeFrame: Admission to hospital until 12 months thereafter
Secondary outcomes:
measure: Comparison of complication rates (any complications and major complications) at 12 months follow-up
timeFrame: Admission to hospital until 12 months thereafter
measure: Specific complication aspects with respect to phrenic nerve palsy and PV stenosis
timeFrame: Admission to Hospital until 12 months thereafter
measure: 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
timeFrame: Admission to Hospital until 12 months thereafter
measure: Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI
timeFrame: Admission to Hospital until 12 months thereafter
measure: Real-time ECG-monitoring of PV-isolation during freezing: Does the microcircular mapping catheter add significant benefit to the cryoballoon procedure
timeFrame: Admission to Hospital until 12 months thereafter
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Mission Hospital, Inc.
state: North Carolina
city: Linz
country: Austria
facility: Allgemeines KH Linz
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bad Neustadt
country: Germany
facility: Herz- und Gefäßklinik Bad Neustadt; Klinik für Kardiologie II
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin (Kardiologie)
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Bielefeld
country: Germany
facility: Klinikum Bielelfeld - Klinik für Kardiologie und internistische Intensivmedizin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn (Med. Klinik und Poliklinik II)
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Dresden
country: Germany
facility: Praxisklinik Herz und Gefäße
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen; Klinik für Kardiologie und Angiologie
city: Frankfurt
country: Germany
facility: Städt. Klinikum Frankfurt Höchst
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien - CCB
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum
city: Hannover
country: Germany
facility: Klinikum Siloah
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Hildesheim
country: Germany
facility: Städt. Klinikum Hildesheim
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum GmbH
city: Köln
country: Germany
facility: St. Vinzenz Hospital Köln-Nippes
city: Lübeck
country: Germany
facility: Universitätsklinik Schleswig-Holstein Campus Lübeck
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: München
country: Germany
facility: Isar Herzzentrum München
city: München
country: Germany
facility: Krankenhaus München Bogenhausen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Traunstein
country: Germany
facility: Klinikum Traunstein
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar-Klinikum Villingen-Schwenningen GmbH
city: Athens
country: Greece
facility: Evangelismos General Hospital
city: Johannesburg
country: South Africa
facility: Sunninghill Hospital
city: Panorama
country: South Africa
facility: Panorama Medi-Clinic
city: Parktown West
country: South Africa
facility: Milpark Hospital
city: El Palmar - Murcia
country: Spain
facility: University Hospital Virgen de la Arrixaca
Study officials:
affiliation: Klinikum Bogenhausen, München
name: Ellen Hoffmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoffmann E, Straube F, Wegscheider K, Kuniss M, Andresen D, Wu LQ, Tebbenjohanns J, Noelker G, Tilz RR, Chun JKR, Franke A, Stellbrink C, Garcia-Alberola A, Dorwarth U, Metzner A, Ouarrak T, Brachmann J, Kuck KH, Senges J; FREEZE Cohort Study Investigators. Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation. Europace. 2019 Sep 1;21(9):1313-1324. doi: 10.1093/europace/euz155.
citation: Straube F, Dorwarth U, Ammar-Busch S, Peter T, Noelker G, Massa T, Kuniss M, Ewertsen NC, Chun KR, Tebbenjohanns J, Tilz R, Kuck KH, Ouarrak T, Senges J, Hoffmann E; FREEZE Cohort Investigators. First-line catheter ablation of paroxysmal atrial fibrillation: outcome of radiofrequency vs. cryoballoon pulmonary vein isolation. Europace. 2016 Mar;18(3):368-75. doi: 10.1093/europace/euv271. Epub 2015 Oct 25.
citation: 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.