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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 (RevealĀ® 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac surgery patients | Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac rhythm monitor implantation | Procedure | post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation burden development after surgical ablation therapy | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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patients who are scheduled for cardiac surgery and who also present with any kind of atrial fibrillation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thorsten Hanke, MD | Contact | 0049-451-500 | 2108 | Thorsten.Hanke@uk-sh.de |
| Name | Affiliation | Role |
|---|---|---|
| Hans-H. Sievers, M.D. | Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany | Study Director |
| Thorsten Hanke, M.D. | Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, germany |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany | Recruiting | Lübeck | Schleswig-Holstein | 23538 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19752365 | Result | 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. | |
| 24665972 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| RevealĀ® XT 9525 | Device | 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. |
|
| Ulrich Stierle, M.D. | Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany | Study Chair |
| Derived |
| 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. |
| 24563690 | Derived | 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. |
| 22824434 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |