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.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Schleswig-Holstein
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Luebeck、Schleswig-Holstein、ドイツ、23538
- 募集
- Clinic for Cardiac and Thoracic Vascular Surgery, University of Lübeck, Germany
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コンタクト:
- Hans-H. Sievers, M.D.
- 電話番号:2108 0049451500
- メール:h.sievers@herzchirurgie-luebeck.de
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コンタクト:
- Thorsten Hanke, M.D.
- 電話番号:2108 0049451500
- メール:Thorsten.Hanke@uk-sh.de
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.)
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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
他の名前:
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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Atrial fibrillation burden development after surgical ablation therapy
時間枠:3 years
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3 years
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二次結果の測定
結果測定 |
時間枠 |
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Comparison of different cardiac rhythm documentation strategies to define success after ablation therapy
時間枠:3 years
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3 years
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協力者と研究者
スポンサー
捜査官
- スタディディレクター:Hans-H. Sievers, M.D.、Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
- 主任研究者:Thorsten Hanke, M.D.、Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
- スタディチェア:Ulrich Stierle, M.D.、Clinic for Cardiac and Thoracic Vascular Surgery, University of Luebeck, Germany
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 08-046
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Cardiac rhythm monitor implantationの臨床試験
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Medtronic Cardiac Rhythm and Heart Failure募集