- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00806689
Full Disclosure Observational Cardiac Rhythm Documentation Follow-up After Surgical Atrial Fibrillation Therapy
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Schleswig-Holstein
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Luebeck, Schleswig-Holstein, Tyskland, 23538
- Rekruttering
- Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany
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Kontakt:
- Hans-H. Sievers, M.D.
- Telefonnummer: 2108 0049451500
- E-mail: h.sievers@herzchirurgie-luebeck.de
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Kontakt:
- Thorsten Hanke, M.D.
- Telefonnummer: 2108 0049451500
- E-mail: Thorsten.Hanke@uk-sh.de
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Cardiac surgery patients
Patients in atrial fibrillation being scheduled for cardiac surgery and concomitant ablation procedure
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post surgical procedure implantation of insertable event recorder for long time heart rhythm surveillance afte ablation therapy
Andre navne:
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Atrial fibrillation burden development after surgical ablation therapy
Tidsramme: 3 years
|
3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy
Tidsramme: 3 years
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3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Hans-H. Sievers, M.D., Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
- Ledende efterforsker: Thorsten Hanke, M.D., Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
- Studiestol: Ulrich Stierle, M.D., Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
Publikationer og nyttige links
Generelle publikationer
- 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. Erratum In: Circulation. 2012 Sep 25;126(13):e216.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 08-046
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