Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation (SCS-PAF)
2016年4月5日 更新者：Medtronic BRC
Patients will be randomized to control and spinal cord stimulation arm (SCS) to investigate the effect of SCS on the occurrence of post-operative atrial fibrillation in the five days after surgery.
調査の概要
状態
終了しました
条件
詳細な説明
Pre market single center clinical research feasibility study. Non blinded randomized controlled study. 52 patients undergoing CABG procedure will be enrolled and randomized into two different group (26 person each): the Spinal Cord Stimulation (SCS) and the control group. The first group will be implanted before the CABG procedure with a temporary SCS lead (5 days) while the second one will not. The lead will be connected to an external stimulator.
The day of the CABG surgery, before the scheduled procedure, the patients in the treatment group will be implanted with the SCS lead. CABG procedure follows the SCS lead implantation. SCS will be switched off before surgery.
After the CABG procedure, all patients will be hospitalized for minimally five days at the end of which they will be discharged. The Primary Endpoint data will be collected from the day of CABG procedure (Day-0) until Day-5. SCS lead will be removed on Day-5.
1-week follow up visit will be performed one week after discharge. End-points will be evaluated at various time before, during and after surgery. In both groups arrhythmic episodes for primary and secondary endpoints will be recorded via a Holter monitor (recording 5 days continuously).
研究の種類
介入
入学 (実際)
4
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Enschede、オランダ、7511 JX
- Medisch Spectrum Twente (MST)
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients which will be subjected to an OFF-pump CABG procedure
- More than 18 years of age
- Subject is able and willing to give informed consent.
Exclusion Criteria:
- Patients with known history of atrial arrhythmias.
- Patients who are not treated with β-blockers unless heart rate is too low for β-blockers assumption.
- Participation in another clinical trial which may affect the outcome within 3 months prior to day of procedure.
- Other surgical interventions (e.g. valve replacement) programmed in the same surgical session
- Resting pulse rate ≤45 beats / min as assessed before daily doses of β-blockage is administered.
- Hypotension (RR systolic <100 or RR diastolic <50).
- Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complete bundle branch block.
- Subject is diagnosed with epilepsy or history of seizures.
- Coagulation abnormalities as determined by anticoagulation guidelines for neuroaxial procedures 2011.
- Patients not stabilized on an anti-arrhythmic drug regimen for the last 30 days.
- Patients with long QT syndrome.
- Patients with Brugada syndrome.
- Patients affected by Polyneuropathy (e.g. due to diabetes).
- Patients affected by pericarditis
Patients who underwent procedures in the past, which are expected to have changed the innervation of the heart for example:
- Ablation procedure
- Cardiac surgery
- Pregnant patients or nursing (subjects who are of child bearing potential and are not on a reliable form of birth control will undergo a pregnancy test)
- Patients already implanted with cardiac devices
- Patients with existing implanted neurostimulators
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Conventional treatment
Non interventional group, patients that belong to this arm will receive the conventional treatment for CABG and they will wear the Holter for 5 days.
|
To measure primary endpoint and most of the secondary endpoints in all the patients enrolled in the study.
The recording will start to before CABG procedure and will be stop at day 5.
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実験的：Spinal Cord Stimulation System
This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.
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To measure primary endpoint and most of the secondary endpoints in all the patients enrolled in the study.
The recording will start to before CABG procedure and will be stop at day 5.
High frequency stimulation using a catheter placed in the lumen of the spine to inhibit sympathetic outflow to the heart
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Atrial fibrillation
時間枠：5 days after CABG
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AT/AF will be defined as an episode with an atrial rate >175 bpm lasting ≥ 20 seconds.
|
5 days after CABG
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Medication
時間枠：5 days after CABG
|
Description of integral medication related to AT/AF occurrence and pain in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
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5 days after CABG
|
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Cardioversion
時間枠：5 days after CABG
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Description of number of cardioversion needed in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
|
5 days after CABG
|
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Hospitalizations Days
時間枠：1 week after discharge
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Description of hospitalizations longer than 5 days as required by the protocol and clinical practice in the treatment (SCS) and control group.
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1 week after discharge
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BP
時間枠：5 days after CABG
|
Description of 1) intra arterial blood pressure as averaged over the first 24 hours after surgery and 2) arterial blood pressure as determined using a blood pressure cuff at a specific time on Day-2, Day-3, Day-4 and Day-5 after surgery in the treatment (SCS) and control group.
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5 days after CABG
|
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Description of the total number of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
時間枠：5 days after CABG
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AT/AF episodes
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5 days after CABG
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Description of burden of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
時間枠：5 days after CABG
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AT/AF burden
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5 days after CABG
|
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Premature atrial beats
時間枠：5 days after CABG
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Description of the amount of premature atrial beats in the treatment (SCS) and control group from the end of the procedure till Day-5 after surgery.
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5 days after CABG
|
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VT/VF episodes
時間枠：5 days after CABG
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Description of the total number of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
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5 days after CABG
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Burden VT/VF episodes
時間枠：5 days after CABG
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Description of the burden of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
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5 days after CABG
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HRV
時間枠：5 days after CABG
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Improvement LF/HF ratio of Heart Rate Variability (HRV) by SCS.
SCS On and Off will be compared in each patients in the treatment (SCS) group before surgery and 5 days after surgery.
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5 days after CABG
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Pain on the VAS scale
時間枠：5 days after CABG
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Description of pain-score due to CABG surgery measured with a VAS score three times a from Day-1 till Day-5 after surgery in the treatment (SCS) and control group.
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5 days after CABG
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Bladder function
時間枠：5 days after CABG
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The extra time the bladder catheter will be kept in the patients after the first 2 days after surgery will be described in the treatment (SCS) and control group in order to assess bladder function.
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5 days after CABG
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HR
時間枠：5 days after CABG
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Description of 1) heart rate as averaged over the first 24 hours after surgery and 2) heart rate as determined using a blood pressure cuff at a specific time on Day-2, Day-3, Day-4 and Day-5 after surgery in the treatment (SCS) and control group.
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5 days after CABG
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jan Diephuis, PhD、Medisch Spectrum Twente
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年2月1日
一次修了 (実際)
2016年2月1日
研究の完了 (実際)
2016年2月1日
試験登録日
最初に提出
2015年5月11日
QC基準を満たした最初の提出物
2015年8月19日
最初の投稿 (見積もり)
2015年8月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年4月6日
QC基準を満たした最後の更新が送信されました
2016年4月5日
最終確認日
2016年4月1日
詳しくは
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。