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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

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring sinus rhythm, atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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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