AF有効性試験の外科的アブレーション (SAFE)
SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.
調査の概要
詳細な説明
Atrial fibrillation (AF) affects more than 1% of the general population and is an important risk factor for stroke. AF prevalence increases with age, occurring in 10 to 15% of patients older than 80 years of age, which is important with the aging population. Of patients undergoing cardiac surgery, 10.8% have a history of AF. AF is believed to cause the left atrium to dilate and lose its transport function. AF significantly increases the risk of ischemic stroke of cardioembolic origin, but is also associated with heart failure and impairs quality of life. Although the causal relationship between the 2 clinical entities has not been fully elucidated, AF is believed to cause heart failure via several mechanisms.
Ablation of AF is the application of scars to the atrial tissue to disrupt faulty electrical signals that cause the arrhythmia. If surgical ablation of AF yields a benefit similar to catheter-based AF ablation, thousands of people undergoing cardiac surgery could benefit from this procedure each year. SAFE will be a landmark trial in cardiac surgery, definitely establishing surgical AF ablation's impact on cardiovascular outcomes. Cardiac surgery is the optimal setting to establish whether maintenance of sinus rhythm through AF ablation yields clinical benefit, and is a setting where sham-control is possible. This will not only provide evidence for the cardiac surgical patients but will bolster the evidence for ablation (catheter or stand-alone surgical) in other AF patients.
The intervention under investigation is concomitant surgical AF ablation which is compared to no surgical AF ablation. The primary outcome is hospital readmissions with heart failure during 4 years of follow-up. This study will enroll 2000 patients from 50 centres, globally. Patients will be followed at hospital discharge, 4 to 6 weeks after surgery, 6 months after surgery, and then at 6-month intervals until the final follow-up visit, for a median follow-up for 4 years.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Richard Whitlock
- 電話番号：905-521-2100
- メール：Richard.Whitlock@phri.ca
研究連絡先のバックアップ
- 名前：SAFE Coordinators
- メール：SAFE@phri.ca
研究場所
-
-
Ontario
-
Hamilton、Ontario、カナダ、L8L 2X2
- 募集
- Hamilton General Hospital
-
コンタクト：
- Richard Whitlock, MD PhD FRCSC
- 電話番号：40306 905-527-4322
- メール：richard.whitlock@phri.ca
-
主任研究者：
- Richard Whitlock, MD MSc FRCSC
-
-
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
説明
Inclusion Criteria:
- Age ≥ 18 years;
- Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof;
- Documented history of paroxysmal or persistent AF
- Provide informed consent
Exclusion Criteria:
-
Dominant atrial arrhythmia is atrial flutter;
-
Documented left atrial diameter ≥ 6 cm;
-
Previous cardiac surgery requiring opening of the pericardium;
-
Patients undergoing any of the following procedures:
- Heart transplant
- Complex congenital heart surgery
- Sole indication for surgery is ventricular assist device insertion
- Mitral valve repair or replacement
- Tricuspid valve repair or replacement
-
Patient resides in a long-term care facility
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
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Surgical Atrial Fibrillation Ablation Group
Surgeon will perform left atrial ablation during patient's cardiac surgery procedure. |
Surgeon will preform surgical atrial fibrillation ablation using either cryoablation or bipolar radiofrequency clamps including 2 layers of atrium or vein, a minimum of 2 burns per clamping with at least 3 lines in the ablation group. Cavo-tricuspid isthmus and mitral lines will be allowed. |
|
介入なし：No Surgical Atrial Fibrillation Ablation Group
Surgeon will not perform left atrial ablation during the patient's cardiac surgery procedure. |
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 |
|---|---|---|
|
Number of hospital readmissions for heart failure over duration of follow-up
時間枠：Common termination point for trial (median follow-up of 4 years)
|
Total number of hospital readmissions for heart failure. |
Common termination point for trial (median follow-up of 4 years)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Ischemic stroke or systemic arterial embolism events over duration of follow up
時間枠：Common termination point for trial (median follow-up of 4 years)
|
Number of Ischemic stroke or systemic arterial embolism events over duration of follow up |
Common termination point for trial (median follow-up of 4 years)
|
|
Length of ICU stay
時間枠：From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
Length of ICU stay, including readmissions, from study intervention surgery to hospital discharge, including readmissions |
From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
|
Length of hospital stay
時間枠：From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
Length of hospital stay |
From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
|
Freedom from recurrence of atrial tachyarrhythmia
時間枠：1 year post-operatively
|
Freedom from recurrence of atrial tachyarrhythmia |
1 year post-operatively
|
|
Number of days free from admission to healthcare facility or presentation to the emergency department for heart failure
時間枠：Common termination point for trial (median follow-up of 4 years)
|
Number of days free admission to healthcare facility or presentation to the emergency department for heart failure |
Common termination point for trial (median follow-up of 4 years)
|
|
All-cause mortality
時間枠：Common termination point for trial (median follow-up of 4 years)
|
All-cause mortality |
Common termination point for trial (median follow-up of 4 years)
|
|
Cardiovascular mortality
時間枠：Common termination point for trial (median follow-up of 4 years)
|
Cardiovascular mortality |
Common termination point for trial (median follow-up of 4 years)
|
|
Antiarrhythmic drug use
時間枠：Beyond 6 weeks until common termination point for trial (median follow-up of 4 years)
|
Antiarrhythmic drug use |
Beyond 6 weeks until common termination point for trial (median follow-up of 4 years)
|
|
Number of patients undergoing atrial fibrillation ablation
時間枠：90 days post- study surgery until common termination point for trial (median follow-up of 4 years)
|
Number of patients undergoing atrial fibrillation ablation |
90 days post- study surgery until common termination point for trial (median follow-up of 4 years)
|
|
Quality of Life - atrial fibrillation specific
時間枠：At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Atrial fibrillation specific quality of life as assessed by the Atrial Fibrillation Effect on QualiTy of Life questionnaire (AFEQT) which is 20 questions using a 7 point Likert scale where a higher score means a worse outcome. |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
|
Quality of Life - heart failure specific
時間枠：At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Heart failure specific quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) which is a 12 questions using Likert scales where a higher score is a better outcome. |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
|
Quality of Life - General
時間枠：At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Quality of life- general as assessed by the European quality of life index version 5D (EQ-5D-5L) which consists of a descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Ischemic stroke and systemic arterial embolism
時間枠：Up to 30 days post-operatively
|
Safety outcome |
Up to 30 days post-operatively
|
|
Number of patients requiring permanent pacemaker implantation
時間枠：Up to 1 year post-operatively
|
Safety outcome |
Up to 1 year post-operatively
|
|
Volume of chest tube output
時間枠：Up to 24 hours post-operatively
|
Safety outcome - chest tube output measured in mL. |
Up to 24 hours post-operatively
|
|
Re-operation for bleeding
時間枠：From date of study intervention surgery completion to date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
Safety outcome |
From date of study intervention surgery completion to date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
|
|
All-cause mortality
時間枠：Prior to discharge or within 30 days post-operatively (whichever occurs first)
|
Safety outcome |
Prior to discharge or within 30 days post-operatively (whichever occurs first)
|
|
Post-operative major bleeding
時間枠：<48 hours after surgery
|
Safety outcome |
<48 hours after surgery
|
|
Number of patients with pulmonary vein stenosis
時間枠：At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Safety outcome |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
|
Number of patients with stiff left atrium syndrome
時間枠：At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Safety outcome |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
|
Number of patients with esophageal to atrial fistula
時間枠：At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
Safety outcome |
At 1 year, and at common termination point for trial (median follow-up of 4 years)
|
|
Health economic analysis of surgical atrial fibrillation
時間枠：At 1 year, and at common termination point (median follow-up of 4 years)
|
Economic analysis will be assessed via health care utilization by patients |
At 1 year, and at common termination point (median follow-up of 4 years)
|
|
Health economic analysis of surgical atrial fibrillation
時間枠：At 1 year, and at common termination point (median follow-up of 4 years)
|
Economic analysis will be assessed via a questionnaire of health care visits and costs incurred by patients. |
At 1 year, and at common termination point (median follow-up of 4 years)
|
協力者と研究者
捜査官
- 主任研究者：Richard Whitlock、Population Health Research Institute
- 主任研究者：Emilie Belley-Côté、Population Health Research Institute
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
キーワード
その他の研究ID番号
- SAFEV1.0
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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