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

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00806689
• Other study ID #: 08-046
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2008
• Last updated: July 1, 2010
• Start date: July 2007
• Est. completion date: July 2011

Study information

• Verified date: December 2008
• Source: University of Luebeck
• Contact: Thorsten Hanke, MD
• Phone: 0049-451-500
• Email: Thorsten.Hanke[@]uk-sh.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2011
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Cardiac rhythm monitor implantation
post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy

Device:
• Reveal® XT 9525
During cardiac surgery after stand alone or concomitant ablation procedure, an insertable loop recorder will be implanted subcutaneously in left pectoral region. After surgery, patients will be monitored regularly in a quarterly basis by performing telemetry of the device in the outpatient clinic. Furthermore, home telemetry will be performed once a month for optimal heart rhythm observation.

Locations

Country	Name	City	State
Germany	Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany	Luebeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hanke T, Charitos EI, Stierle U, Karluss A, Kraatz E, Graf B, Hagemann A, Misfeld M, Sievers HH. Twenty-four-hour holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation burden development after surgical ablation therapy		3 years	No
Secondary	Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy		3 years	No