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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05023590
Other study ID # VHA17-Registry
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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