Atrial Fibrillation Registry 2017
Primary Purpose
Atrial Fibrillation, Mitral Valve Failure
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ablation of left atrium during mitral valve open chest intervention
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring sinus rhythm, atrial fibrillation
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
Sites / Locations
- Herz- und Gefaesszentrum Bad Bevensen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
cryo ablation
radio frequency ablation
Arm Description
cryo ablation of left atrium during mitral valve open chest intervention
radio frequency ablation of left atrium during mitral valve open chest intervention
Outcomes
Primary Outcome Measures
number of patients with stabil sinus rhythm 6 month after ablation
number of patients with stabil sinus rhythm 6 month after ablation
Secondary Outcome Measures
Full Information
NCT ID
NCT05023590
First Posted
May 5, 2021
Last Updated
August 24, 2021
Sponsor
Herz- und Gefaesszentrum Bad Bevensen
1. Study Identification
Unique Protocol Identification Number
NCT05023590
Brief Title
Atrial Fibrillation Registry 2017
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Herz- und Gefaesszentrum Bad Bevensen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Mitral Valve Failure
Keywords
sinus rhythm, atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
monocentric, 1:1 randomized (cryo ablation vs. radiofrequency ablation), open-label, parallel, registry
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cryo ablation
Arm Type
Active Comparator
Arm Description
cryo ablation of left atrium during mitral valve open chest intervention
Arm Title
radio frequency ablation
Arm Type
Active Comparator
Arm Description
radio frequency ablation of left atrium during mitral valve open chest intervention
Intervention Type
Procedure
Intervention Name(s)
ablation of left atrium during mitral valve open chest intervention
Intervention Description
open chest mitral valve surgery (reconstruction or replacement) with additional ablation of left atrium by cryo or radio frequency method
Primary Outcome Measure Information:
Title
number of patients with stabil sinus rhythm 6 month after ablation
Description
number of patients with stabil sinus rhythm 6 month after ablation
Time Frame
6 month after index surgery / ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Wimmer-Greinecker, Prof.
Organizational Affiliation
Herz- und Gefäßzentrum Bad Bevensen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz- und Gefaesszentrum Bad Bevensen
City
Bad Bevensen
State/Province
Lower Saxony
ZIP/Postal Code
29549
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Atrial Fibrillation Registry 2017
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