Atrial Fibrillation Registry 2017

Not Applicable

• Conditions: Mitral Valve Failure; Atrial Fibrillation
• Interventions: Procedure: ablation of left atrium during mitral valve open chest intervention

• 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.

Study Timeline

• Study Start: 2017-02-22
• Study First Submitted: 2021-05-05
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-24
• Last Update Submitted: 2021-08-24
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26
• Primary Completion: 2022-12-30
• Study Completion: 2023-07-31

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

Arm && Interventions

Group	Intervention	Description
cryo ablation	ablation of left atrium during mitral valve open chest intervention	cryo ablation of left atrium during mitral valve open chest intervention
radio frequency ablation	ablation of left atrium during mitral valve open chest intervention	radio frequency ablation of left atrium during mitral valve open chest intervention

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

Trial Locations

Locations (1)

Herz- und Gefaesszentrum Bad Bevensen; 🇩🇪 Bad Bevensen, Lower Saxony, Germany