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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University of Luebeck.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00806689
First received: December 10, 2008
Last updated: July 1, 2010
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention
Atrial Fibrillation
 Procedure: Cardiac rhythm monitor implantation
Device: Reveal® XT 9525

Study Type: Observational
Study Design: Observational Model: Cohort

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Atrial fibrillation burden development after surgical ablation therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cardiac surgery patients
Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure
 Procedure: Cardiac rhythm monitor implantation
post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy
Other Name: Reveal® XT 9525, Medtronic Inc., Minneapolis, MN, USA
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.
Other Name: Reveal® XT 9525

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients who are scheduled for cardiac surgery and who also present with any kind of atrial fibrillation.

Criteria

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806689

Contacts
Contact: Thorsten Hanke, MD 0049-451-500 ext 2108 Thorsten.Hanke@uk-sh.de

Locations
Germany
Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany Recruiting
Luebeck, Schleswig-Holstein, Germany, 23538
Contact: Hans-H. Sievers, M.D.     0049451500 ext 2108     h.sievers@herzchirurgie-luebeck.de    
Contact: Thorsten Hanke, M.D.     0049451500 ext 2108     Thorsten.Hanke@uk-sh.de    
Sponsors and Collaborators
University of Luebeck
Investigators
Study Director: Hans-H. Sievers, M.D. Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany
Principal Investigator: Thorsten Hanke, M.D. Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany
Study Chair: Ulrich Stierle, M.D. Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. med. Hans-H. Sievers, Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck
ClinicalTrials.gov Identifier: NCT00806689     History of Changes
Other Study ID Numbers: 08-046
Study First Received: December 10, 2008
Last Updated: July 1, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Luebeck:
heart rhythm surveillance
follow-up
atrial fibrillation success

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013