- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Thorsten Hanke, MD
- 전화번호: 2108 0049-451-500
- 이메일: Thorsten.Hanke@uk-sh.de
연구 장소
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Schleswig-Holstein
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Luebeck, Schleswig-Holstein, 독일, 23538
- 모병
- Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany
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연락하다:
- Hans-H. Sievers, M.D.
- 전화번호: 2108 0049451500
- 이메일: h.sievers@herzchirurgie-luebeck.de
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연락하다:
- Thorsten Hanke, M.D.
- 전화번호: 2108 0049451500
- 이메일: Thorsten.Hanke@uk-sh.de
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
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
다른 이름들:
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Atrial fibrillation burden development after surgical ablation therapy
기간: 3 years
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3 years
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy
기간: 3 years
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3 years
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공동 작업자 및 조사자
수사관
- 연구 책임자: Hans-H. Sievers, M.D., Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
- 수석 연구원: Thorsten Hanke, M.D., Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
- 연구 의자: Ulrich Stierle, M.D., Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 08-046
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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