Atrial Fibrillation Clinical Trial
Official title:
Monocentric, Randomized, Prospective Study to Compare Endocardiac Radio Frequency Ablation and Cryo Ablation of the Left Atrium During an Open Chest Mitral Valve Intervention
Verified date | August 2021 |
Source | Herz- und Gefaesszentrum Bad Bevensen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Monocentric, prospective, randomized trial of cardiac surgical arrhythmia using endocardial radiofrequency atrial ablation compared with a cryo ablation system in the setting of cardiac surgery.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | July 31, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients = 18 years - Present, written informed consent from the patient - paroxysmal, persistent, or permanent atrial fibrillation not longer than 10 years according to guidelines (ACC, AHA, ESC) - planned cardiac surgery on the mitral valve - ECHO parameters : LA size a.p. = 55mm Exclusion Criteria: - permanent atrial fibrillation longer than 10 years - ECHO parameters : LA size a.p. > 55mm - pregnancy - life expectancy < 12 months - lack of cognitive or mental capacity to participate in the study - Patients who are to be included in another clinical (interventional) study at the same time or who are already participating in such a study |
Country | Name | City | State |
---|---|---|---|
Germany | Herz- und Gefaesszentrum Bad Bevensen | Bad Bevensen | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
Herz- und Gefaesszentrum Bad Bevensen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of patients with stabil sinus rhythm 6 month after ablation | number of patients with stabil sinus rhythm 6 month after ablation | 6 month after index surgery / ablation |
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