Full Disclosure Observational Cardiac Rhythm Documentation Follow-up After Surgical Atrial Fibrillation Therapy

University of Luebeck

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: Cardiac rhythm monitor implantation; Device: Reveal® XT 9525

Study type: Observational

Funder types: Other

Identifiers

NCT00806689

08-046

Details and patient eligibility

About

24 hour Holter monitoring (24HM) is commonly used to assess cardiac rhythm after surgical therapy of atrial fibrillation. This "snapshot" rhythm documentation leaves a large diagnostic window of non recorded atrial arrhythmias and as such a large amount of uncertainty in follow-up result assessment. To improve accuracy of rhythm surveillance thus gaining a more "real-life" scenario of post surgical ablation therapy cardiac rhythm a new insertable cardiac rhythm monitor device (Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA) with full observational continuous heart rhythm documentation is implanted.

In order to verify different follow-up strategies after surgical atrial fibrillation therapy, a comparison of different follow-up scenarios (symptoms, different cardiac documentation devices i.e. ECG and 24 hour Holter monitor, at different follow-up time points) is performed intraindividually. Thus the reliability of these devices and follow-up strategies to define success after ablation therapy is evaluated.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients in atrial fibrillation (AF duration >4 months)being scheduled for cardiac surgery
• patients with lone atrial fibrillation being scheduled for surgical AF treatment

Exclusion criteria

• failure to provide informed consent
• current participation in another clinical trial
• organic cause of atrial fibrillation (hyperthyroidism etc.)

Trial design

100 participants in 1 patient group

Cardiac surgery patients

Description:

Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure

Treatment:

Procedure: Cardiac rhythm monitor implantation

Device: Reveal® XT 9525