Monocentric, Randomized, Prospective Study to Compare Endocardiac Radio Frequency Ablation and Cryo Ablation of the Left Atrium During an Open Chest Mitral Valve Intervention

Herz- und Gefaesszentrum Bad Bevensen1 site in 1 country50 target enrollmentFebruary 22, 2017

ConditionsAtrial Fibrillation Mitral Valve Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Herz- und Gefaesszentrum Bad Bevensen
Enrollment: 50
Locations: 1
Primary Endpoint: number of patients with stabil sinus rhythm 6 month after ablation
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 22, 2017

End Date

July 31, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Herz- und Gefaesszentrum Bad Bevensen

Responsible Party

Sponsor

Eligibility Criteria

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