Atrial Fibrillation Registry 2017

NCT ID: NCT05023590

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-22

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Mitral Valve Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

monocentric, 1:1 randomized (cryo ablation vs. radiofrequency ablation), open-label, parallel, registry
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cryo ablation

cryo ablation of left atrium during mitral valve open chest intervention

Group Type ACTIVE_COMPARATOR

ablation of left atrium during mitral valve open chest intervention

Intervention Type PROCEDURE

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

radio frequency ablation

radio frequency ablation of left atrium during mitral valve open chest intervention

Group Type ACTIVE_COMPARATOR

ablation of left atrium during mitral valve open chest intervention

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herz- und Gefaesszentrum Bad Bevensen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerhard Wimmer-Greinecker, Prof.

Role: PRINCIPAL_INVESTIGATOR

Herz- und Gefäßzentrum Bad Bevensen

Locations

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Herz- und Gefaesszentrum Bad Bevensen

Bad Bevensen, Lower Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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VHA17-Registry

Identifier Type: -

Identifier Source: org_study_id

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