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Atrial Fibrillation Registry 2017

H

Herz- und Gefaesszentrum Bad Bevensen

Status

Unknown

Conditions

Mitral Valve Failure
Atrial Fibrillation

Treatments

Procedure: ablation of left atrium during mitral valve open chest intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05023590
VHA17-Registry

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

cryo ablation
Active Comparator group
Description:
cryo ablation of left atrium during mitral valve open chest intervention
Treatment:
Procedure: ablation of left atrium during mitral valve open chest intervention
radio frequency ablation
Active Comparator group
Description:
radio frequency ablation of left atrium during mitral valve open chest intervention
Treatment:
Procedure: ablation of left atrium during mitral valve open chest intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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