Full Disclosure Observational Cardiac Rhythm Documentation Follow-up After Surgical Atrial Fibrillation Therapy
NCT ID: NCT00806689
Last Updated: 2010-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2007-07-31
2011-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
Study Groups
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Cardiac surgery patients
Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure
Cardiac rhythm monitor implantation
post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy
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.
Interventions
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Cardiac rhythm monitor implantation
post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients with lone atrial fibrillation being scheduled for surgical AF treatment
Exclusion Criteria
* current participation in another clinical trial
* organic cause of atrial fibrillation (hyperthyroidism etc.)
18 Years
ALL
No
Sponsors
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University of Luebeck
OTHER
Responsible Party
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Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck
Principal Investigators
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Hans-H. Sievers, M.D.
Role: STUDY_DIRECTOR
Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany
Thorsten Hanke, M.D.
Role: PRINCIPAL_INVESTIGATOR
Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany
Ulrich Stierle, M.D.
Role: STUDY_CHAIR
Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
Locations
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Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany
Lübeck, Schleswig-Holstein, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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 experience with a novel permanently implantable heart rhythm monitor device. Circulation. 2009 Sep 15;120(11 Suppl):S177-84. doi: 10.1161/CIRCULATIONAHA.108.838474.
Charitos EI, Ziegler PD, Stierle U, Robinson DR, Graf B, Sievers HH, Hanke T. Atrial fibrillation burden estimates derived from intermittent rhythm monitoring are unreliable estimates of the true atrial fibrillation burden. Pacing Clin Electrophysiol. 2014 Sep;37(9):1210-8. doi: 10.1111/pace.12389. Epub 2014 Mar 25.
Charitos EI, Ziegler PD, Stierle U, Robinson DR, Graf B, Sievers HH, Hanke T. How often should we monitor for reliable detection of atrial fibrillation recurrence? Efficiency considerations and implications for study design. PLoS One. 2014 Feb 12;9(2):e89022. doi: 10.1371/journal.pone.0089022. eCollection 2014.
Charitos EI, Stierle U, Ziegler PD, Baldewig M, Robinson DR, Sievers HH, Hanke T. A comprehensive evaluation of rhythm monitoring strategies for the detection of atrial fibrillation recurrence: insights from 647 continuously monitored patients and implications for monitoring after therapeutic interventions. Circulation. 2012 Aug 14;126(7):806-14. doi: 10.1161/CIRCULATIONAHA.112.098079. Epub 2012 Jul 23.
Other Identifiers
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08-046
Identifier Type: -
Identifier Source: org_study_id
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