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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryo ablation | Patients with first Ablation of atrial fibrillation treated by cryo ablation | ||
| RF ablation | Patients with first Ablation of atrial fibrillation treated by Radio frequency ablation |
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| Measure | Description | Time Frame |
|---|---|---|
| AF recurrency rate (any detected episode lasting > 30 sec) at 12 months follow up | Admission to hospital until 12 months thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of complication rates (any complications and major complications) at 12 months follow-up | Admission to hospital until 12 months thereafter | |
| Specific complication aspects with respect to phrenic nerve palsy and PV stenosis | Admission to Hospital until 12 months thereafter |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with AF ablation targeting
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Hoffmann, MD | Klinikum Bogenhausen, München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mission Hospital, Inc. | Asheville | North Carolina | 28803 | United States | ||
| Allgemeines KH Linz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37681996 | Derived | Pongratz J, Kuniss M, Wu L, Tebbenjohanns J, Nolker G, Dorwarth U, Kuck KH, Jochen S, Hoffmann E, Straube F; FREEZE Cohort Study Investigators. Impact of intracardiac echocardiography usage on the safety of cryoballoon atrial fibrillation ablation: Subanalysis of the prospective FREEZE cluster cohort study. J Cardiovasc Electrophysiol. 2023 Oct;34(10):2029-2039. doi: 10.1111/jce.16060. Epub 2023 Sep 8. | |
| 36624380 |
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De-identified patient data will be published after end of follow up period
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| 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 |
| Persistent AF: Impact on efficacy analyzing procedural aspects in cryoballoon PVI | 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 |
| Linz |
| 4020 |
| Austria |
| Klinikum Aschaffenburg | Aschaffenburg | 63739 | Germany |
| Herz-Zentrum Bad Krozingen | Bad Krozingen | Germany |
| Kerckhoff-Klinik | Bad Nauheim | Germany |
| Herz- und Gefäßklinik Bad Neustadt; Klinik für Kardiologie II | Bad Neustadt an der Saale | 97616 | Germany |
| Herz- und Diabeteszentrum | Bad Oeynhausen | Germany |
| Deutsches Herzzentrum Berlin (Kardiologie) | Berlin | 13353 | Germany |
| Vivantes Klinikum Am Urban | Berlin | Germany |
| Klinikum Bielelfeld - Klinik für Kardiologie und internistische Intensivmedizin | Bielefeld | 33604 | Germany |
| Universitätsklinikum Bonn (Med. Klinik und Poliklinik II) | Bonn | 53105 | Germany |
| Klinikum Coburg | Coburg | Germany |
| St. Vinzenz Hospital Köln-Nippes | Cologne | 50733 | Germany |
| Praxisklinik Herz und Gefäße | Dresden | Germany |
| Elisabeth-Krankenhaus Essen; Klinik für Kardiologie und Angiologie | Essen | 45138 | Germany |
| Städt. Klinikum Frankfurt Höchst | Frankfurt | 65929 | Germany |
| Cardioangiologisches Centrum Bethanien - CCB | Frankfurt | Germany |
| Universitäres Herzzentrum Eppendorf | Hamburg | 20246 | Germany |
| Asklepios Klinik St. Georg | Hamburg | Germany |
| Universitäres Herzzentrum | Hamburg | Germany |
| Klinikum Siloah | Hanover | 30449 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Städt. Klinikum Hildesheim | Hildesheim | Germany |
| Klinikum Ingolstadt | Ingolstadt | 85049 | Germany |
| Westpfalz-Klinikum GmbH | Kaiserslautern | Germany |
| Universitätsklinik Schleswig-Holstein Campus Lübeck | Lübeck | 23538 | Germany |
| Universitätsmedizin Mainz | Mainz | 55131 | Germany |
| Isar Herzzentrum München | München | Germany |
| Krankenhaus München Bogenhausen | München | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Klinikum Traunstein | Traunstein | 83278 | Germany |
| Schwarzwald-Baar-Klinikum Villingen-Schwenningen GmbH | Villingen-Schwenningen | 78052 | Germany |
| Evangelismos General Hospital | Athens | 106 76 | Greece |
| Sunninghill Hospital | Johannesburg | 2196 | South Africa |
| Panorama Medi-Clinic | Panorama | 7500 | South Africa |
| Milpark Hospital | Parktown West | 2193 | South Africa |
| University Hospital Virgen de la Arrixaca | El Palmar - Murcia | 30120 | Spain |
| Derived |
| Metzner A, Straube F, Tilz RR, Kuniss M, Noelker G, Tebbenjohanns J, Andresen D, Wieneke H, Stellbrink C, Franke J, Dorwarth U, Carion PL, Holbrook R, Hochadel M, Senges J, Hoffmann E, Kuck KH; FREEZE Cohort Study Investigators. Electrophysiology lab efficiency comparison between cryoballoon and point-by-point radiofrequency ablation: a German sub-analysis of the FREEZE Cohort study. BMC Cardiovasc Disord. 2023 Jan 9;23(1):8. doi: 10.1186/s12872-022-03015-8. |
| 31199860 | Derived | 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. |
| 26504108 | Derived | 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. |
| 24994074 | Derived | 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. |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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