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

• Conditions: Atrial Fibrillation

• Registration Number: NCT00806689
• Lead Sponsor: University of Luebeck

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Status Verified: 2008-12
• Primary Completion: 2008-12
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Last Update Submitted: 2010-07-01
• Last Update Posted: 2010-07-02
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation burden development after surgical ablation therapy	3 years

Secondary Outcome Measures

Name	Time	Method
Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy	3 years

Trial Locations

Locations (1)

Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany; 🇩🇪 Luebeck, Schleswig-Holstein, Germany