Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins (PARADISO)
Paroxysmal Atrial Fibrillation Repeat Ablation Strategies With Durably Isolated Pulmonary Veins (PARADISO): a Vanguard Study
This study looks at participants who have undergone an ablation procedure for atrial fibrillation previously, and atrial fibrillation has occurred and a second ablation procedure is needed. The study will randomize participants to either a tailored strategy for ablation or to widening the pulmonary vein isolation procedure with or without cavotricuspid isthmus ablation. The goal is to improve freedom from recurrent atrial arrhythmias at 12 months.
調査の概要
詳細な説明
This is a study of patients who have undergone an ablation procedure for AF but in whom AF recurred and who are undergoing a second ablation procedure. Specifically, the investigators are interested in the group of patients whose PVs are still "isolated" during that second procedure because doctors are unsure of how best to ablate them. It is even possible that doing any more ablation in those patients is harmful.
The study will compare (1) an ablation strategy that includes commonly done ablation steps that tackle abnormalities found during the procedure (i.e., ablating "low voltage areas", searching for and ablating other arrhythmias called supraventricular tachycardias, and in some patients ablating the "posterior wall") to (2) an ablation strategy that reinforces or extends the PVI step only. In both groups, cavotricuspid isthmus ablation is also performed, if not already successfully done previously. The vanguard study will follow participants for 1 year, with a 3 year follow up planned if feasibility is met. Participants will be required to wear a Holter monitor at various timepoints and will be asked to complete atrial fibrillation and quality of life questionnaires.
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：Tammy Knight
- 電話番号：613-696-7000
- メール：TKnight@ottawaheart.ca
研究場所
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-
Ontario
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Ottawa、Ontario、カナダ、K1Y 4W7
- University of Ottawa Heart Institute
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副調査官：
- David Birnie, MD
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コンタクト：
- Tammy Knight
- 電話番号：613-696-7000
- メール：tknight@ottawaheart.ca
-
主任研究者：
- F. Daniel Ramirez, MD
-
-
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:
- Paroxysmal atrial fibrillation with durable pulmonary vein isolation (PVI)
- Age >/= 18 years
- at least one episode of atrial fibrillation documented on 12-lead ECG, Holter monitor, or loop recorder in the preceding 12 months
- ability to provide informed consent
Exclusion Criteria:
- Persistent atrial fibrillation
- documented sustained atrial tachycardia or atypical atrial flutter.
- Previous atrial ablation excluding PVI or cavotricuspid Isthmus (CTI) ablation (having undergoing more than one procedure is acceptable as long as only PVI +/- CTI ablation was preformed)
- previous left atrial surgery
- known PV stenosis or history of PV intervention
- active intracardiac thrombus
- contraindication to systemic anticoagulation
- hypertrophic cardiomyopathy
- significant left-sided valve disease (moderate or severe mitral or aortic stenosis or regurgitation)
- significant congenital heart disease, including atrial septal defects or PV abnormalities (patent foramen ovale is not an exclusion)
- active pregnancy
- participation or anticipated participation in another clinical trial that could affect the results of this trial
- unwillingness or inability to adhere fully with study procedures and follow up
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：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 |
|---|---|
|
実験的：Tailored Strategy
Homogenizing left atrium/atrial (LA) low voltage areas (LVAs), ablating inducible supraventricular tachycardia (SVTs), and if no abnormality is identified, performing empiric posterior wall isolation (PWI )followed by cavotricuspid isthmus (CTI) ablation (if successful CTI ablation not performed previously). |
Homogenizing left atrium/atrial (LA) low voltage areas (LVAs), ablating inducible supraventricular tachycardia (SVTs), and if no abnormality is identified, performing empiric posterior wall isolation (PWI )followed by cavotricuspid isthmus (CTI) ablation (if successful CTI ablation not performed previously). |
|
他の：Control Strategy
Widening wide area circumferential ablation (WACA) lines and cavotricuspid isthmus (CTI) ablation if not successfully performed previously. |
Widening wide area circumferential ablation (WACA) lines and cavotricuspid isthmus (CTI) ablation if not successfully performed previously. |
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 |
|---|---|---|
|
Freedom from recurrent atrial arrhythmia lasting >/= 30 seconds
時間枠：Days 57 to 365 from repeat procedure.
|
Atrial arrhythmias include atrial fibrillation, atrial flutter, or atrial tachycardia. |
Days 57 to 365 from repeat procedure.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedure duration
時間枠：From beginning of vascular access to removal of all catheters
|
Time, in minutes, of the repeat procedure |
From beginning of vascular access to removal of all catheters
|
|
Composite of major procedure-related complications
時間枠：Baseline to 12 months
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Procedure-related complications include embolic events, pulmonary vein stenosis, cardiac perforation, major bleeding, atrioesophageal fistula, or death) |
Baseline to 12 months
|
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Emergency Room visits or re-hospitalizations
時間枠：Baseline to 12 months
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Visits and admissions related to recurrent atrial arrhythmias |
Baseline to 12 months
|
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Repeat Catheter Ablation procedure
時間枠：Baseline to 12 months
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Occurrence of additional ablation after the study index procedure. |
Baseline to 12 months
|
|
Atrial Fibrillation Effect on Quality of Life
時間枠：Baseline to 12 months.
|
Measured by the Atrial Fibrillation Effect on Quality of Life questionnaire. Scale of 0-100, with 100 being best quality of life. |
Baseline to 12 months.
|
協力者と研究者
捜査官
- 主任研究者：F. Daniel Ramirez, MD、Ottawa Heart Institute Research Corporation
研究記録日
主要日程の研究
研究開始 (推定)
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
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