Atrial Fibrillation Registry 2017

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05023590
• Other study ID #: VHA17-Registry
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2021
• Source: Herz- und Gefaesszentrum Bad Bevensen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Mitral Valve Failure

Intervention

Procedure:
• ablation of left atrium during mitral valve open chest intervention
open chest mitral valve surgery (reconstruction or replacement) with additional ablation of left atrium by cryo or radio frequency method

Locations

Country	Name	City	State
Germany	Herz- und Gefaesszentrum Bad Bevensen	Bad Bevensen	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Herz- und Gefaesszentrum Bad Bevensen

Country where clinical trial is conducted

Germany, 

Outcome

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