典型的な心房粗動アブレーションのために紹介された患者におけるクライオバルーン肺静脈隔離 (PAF CRIOBLAF)
典型的な心房粗動患者における右地峡アブレーションとクライオバルーン肺静脈隔離術の組み合わせによる心房細動の予防
- Background:
Atrial fibrillation is frequently associated with typical atrial flutter in clinical practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved in most cases without recurrence, it does not prevent the occurrence of atrial fibrillation that occurs in about 70% of these patients after several years of follow-up. However, the latter arrhythmia is associated with significant morbidity and mortality. The problem of atrial fibrillation occurrence after successful ablation of typical atrial flutter remains physicians primary concern in monitoring these patients.
- Objectives:
The purpose of this study is to demonstrate that the pulmonary veins isolation using balloon cryotherapy technology performed at the time of flutter ablation, significantly reduces the risk of developing atrial fibrillation in the two year period following the procedure.
- Selection Criteria:
Patients referred for ablation of typical atrial flutter with an history of at least one documented episode of atrial fibrillation (atrial flutter remaining the predominant arrhythmia)will be enrolled in the study.
- Study Methods:
This is a prospective, multicenter, randomized, 2-arms study, comparing the rate of atrial fibrillation occurrence over a two years period following either an ablation procedure of typical atrial flutter (Group 1), or a combined procedure of typical atrial flutter ablation and pulmonary veins cryoballoon isolation (Group 2). The enrollment period will be of 18 months.
Randomization will be 1:1 and will be balanced in blocks of varying size. Patients will then be regularly followed up clinically and by long-term ECG recordings.
- Evaluation Criteria:
The primary endpoint will be the recurrence of symptomatic or asymptomatic atrial fibrillation, documented by an ECG or an R-test, occurring between M3 and M24
-
Number of patients:
170 patients will be enrolled in the study
-
Number of centers:
Four French and three German centers will participate.
- Perspective:
The demonstration of a clinical benefit in terms of atrial fibrillation risk reduction in the patient group with pulmonary vein isolation, could lead to a modification of atrial arrhythmia treatment indication.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Brest、フランス
- CHU de Brest
-
Grenoble、フランス、38000
- CHU Grenoble
-
La Rochelle、フランス
- CH La Rochelle
-
Marseille、フランス
- AP-HM - Hôpital Nord
-
Marseille、フランス
- Hôpital Privé de Clairval
-
Nantes、フランス
- CHU de Nantes
-
Nantes、フランス
- Nouvelles Cliniques Nantaises
-
Rennes、フランス、35033
- CHU de Rennes
-
Rouen、フランス、76000
- University Hospital of Rouen
-
Strasbourg、フランス
- CHU de Strasbourg
-
Toulouse、フランス、31076
- Clinique Pasteur
-
Tours、フランス
- CHU de Tours
-
Tours、フランス
- Clinique Saint Gatien
-
Trélazé、フランス
- Clinique Saint Joseph
-
Valenciennes、フランス
- Polyclinique Vauban
-
-
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:
- Patient with a spontaneous flutter or with a flutter recurrence when it was not considered appropriate to use a preventive treatment so far. The flutter may have been paroxysmal or may still be present.
- Patient with at least one documented episode of typical flutter defined as follows: negative F waves in the inferior territory, positive in V1 and negative in V6 lead, F wave pattern with characteristic "saw tooth" appearance and finally a heart rate comprised between 240 and 320 beats per minute.
- Patient with effective anticoagulant therapy for at least 3 weeks.
- Patient with at least one episode of AF (lasting more than 1 minute) documented on an ECG or a 24 hour Holter recording
- Patient who signed an informed consent.
- Patient with age ≥ 18 yo and ≤ 75 yo
-
Exclusion Criteria:
-
Patients with the following characteristics will be excluded:
- Contraindication to right-heart catheterization
- Contraindication to an anticoagulant treatment
- Patient for which AF is predominant (more recordings of AF than Flutter)
- Persistent AF at the time of inclusion visit
- History of mitral valve surgery
- Known disorders of blood clotting
- Cardiothyreosis
-
Life expectancy < 24 months
-
Less than 18 years old and pregnant ladies. As before any ablation, a pregnancy test will be done the day before or the day of the procedure
-
Patient less than 18 years old
-
Patient under guardianship
-
Patient deprived of their liberty by a court decision
-
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 |
|---|---|
|
アクティブコンパレータ：Atrial flutter ablation
RF atrial flutter ablation |
Radiofrequency ablation of Atrial flutter |
|
実験的：Atrial flutter ablation and pulmonary vein isolation
RF Atrial flutter ablation and pulmonary vein isolation using cryoablation |
Radiofrequency ablation of atrial flutter and pulmonary vein isolation using cryoablation |
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 |
|---|---|---|
|
Recurrence of symptomatic or asymptomatic AF as documented on an ECG or a long term Holter
時間枠：an average of 24 months following the ablation procedure
|
Main endpoint will be the recurrence of symptomatic or asymptomatic atrial fibrillation as documented by an ECG or a R-test. Sustained AF episodes of more than a minute will be classified depending if they are symptomatic or not. |
an average of 24 months following the ablation procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recurrence rate of typical atrial flutter
時間枠：an average of 24 months following the ablation procedure
|
Recurrence rate of typical atrial flutter |
an average of 24 months following the ablation procedure
|
|
Rate of occurrence of atypical flutter
時間枠：an average of 24 months following the ablation procedure
|
Occurrence rate of atypical flutter defined as a continuous atrial activity (with no return to the isoelectric line)in at least one lead, whose ECG appearance of F waves is different from that of a typical flutter |
an average of 24 months following the ablation procedure
|
|
Rate of occurrence of atrial tachycardia
時間枠：an average of 24 months following the ablation procedure
|
Rate of occurrence of atrial tachycardia defined as an atrial activaty that generates a P wave with return to the isoelectric line in all leads |
an average of 24 months following the ablation procedure
|
|
Rate of complications related to the ablation procedure
時間枠：an average of 3 months after the ablation procedure
|
The following complications will be considered: Hematoma at punction site, Thromboembolic accident, Tamponnade, Phrenic nerve paralysis, Symptomatic stenosis of pulmonary vein, Atrio-ventricular block Atrioesophageal fistula |
an average of 3 months after the ablation procedure
|
|
Rate of major cardiovascular events
時間枠：an average of 24 months following the ablation procedure
|
Rate of major cardiovascular events such as rehospitalization for arrhythmia, heart failure, or embolic accident |
an average of 24 months following the ablation procedure
|
|
All mortality rate
時間枠：an average of 24 months following the ablation procedure
|
All mortality rate (including sudden death and any type of death) |
an average of 24 months following the ablation procedure
|
協力者と研究者
協力者
捜査官
- 主任研究者：Frederic Anselme, MD、University Hospital, Rouen
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (推定)
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
- 2011/089/HP
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