Atrial Fibrillation Registry 2017
Not Applicable
- Conditions
- Mitral Valve FailureAtrial Fibrillation
- Registration Number
- NCT05023590
- Lead Sponsor
- Herz- und Gefaesszentrum Bad Bevensen
- Brief Summary
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.
- Detailed Description
Regular, rhythmic monitoring (24-hour Holter ECG, 5 and 28 days, 3 and 6 months po) of patients after cardiac surgery on the mitral valve with atrial ablation for paroxysmal, persistent, and permanent atrial fibrillation with regard to the presence or stability of sinus rhythm.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method number of patients with stabil sinus rhythm 6 month after ablation 6 month after index surgery / ablation number of patients with stabil sinus rhythm 6 month after ablation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Herz- und Gefaesszentrum Bad Bevensen
🇩🇪Bad Bevensen, Lower Saxony, Germany
Herz- und Gefaesszentrum Bad Bevensen🇩🇪Bad Bevensen, Lower Saxony, Germany