FREEZE Cohort Study

Completed

Conditions studied: Arrhythmia

In brief

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.

Key facts

Study ID

NCT01360008

Run by

Stiftung Institut fuer Herzinfarktforschung

People needed

4071

Starts

2011-04-01

Expected to finish

2017-04-01

Last updated by the study team

2019-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 an der Saale, 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
• St. Vinzenz Hospital Köln-Nippes — Cologne, Germany
• Praxisklinik Herz und Gefäße — Dresden, Germany
• Elisabeth-Krankenhaus Essen; Klinik für Kardiologie und Angiologie — Essen, Germany
• Städt. Klinikum Frankfurt Höchst — Frankfurt, Germany
• Cardioangiologisches Centrum Bethanien - CCB — Frankfurt, Germany
• Universitäres Herzzentrum Eppendorf — Hamburg, Germany
• Asklepios Klinik St. Georg — Hamburg, Germany
• Universitäres Herzzentrum — Hamburg, Germany
• Klinikum Siloah — Hanover, Germany
• Universitätsklinikum Heidelberg — Heidelberg, Germany
• Städt. Klinikum Hildesheim — Hildesheim, Germany
• Klinikum Ingolstadt — Ingolstadt, Germany
• Westpfalz-Klinikum GmbH — Kaiserslautern, Germany

Full record on ClinicalTrials.gov

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