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

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Cardiac rhythm monitor implantation; Device: Reveal® XT 9525

• 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

Arm && Interventions

Group	Intervention	Description
Cardiac surgery patients	Reveal® XT 9525	Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure
Cardiac surgery patients	Cardiac rhythm monitor implantation	Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure

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