FIRM as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
Focal Impulse and Rotor Modulation (FIRM) as a Stand-alone Procedure in the Treatment of Atrial Fibrillation
調査の概要
詳細な説明
After a pilot/implementation study consisting of 10 patients with paroxysmal atrial fibrillation (AF); 20 patients with paroxysmal AF will be included in a within-patient trial. This study will be followed by a similar comparison in 20 patients with persistent or longstanding persistent AF.
The AF driving sources will be visualized by a novel sequential bi-atrial panoramic contact mapping technique. Unipolar signals will be recorded by a 64-polar basket catheter (FIRMap®, Topera. Inc.), then processed and the activation patterns visualized (RhythmView® 3D Electrophysiologic Mapping System, Topera, Inc.).
Focal impulse and rotor modulation (FIRM) will then be performed with standard irrigated radio frequency catheter ablation until rotor or focal impulse elimination is confirmed by repeat FIRM mapping.
Treatment efficacy will be assessed with continuous heart rhythm monitors (Reveal XT®, Medtronic, Minneapolis, USA) implanted 3 months prior to ablation, and freedom from AF defined as AF burden <1% at follow-up at 12, 24 and 30 months.
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
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Oslo、ノルウェー
- Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
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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
説明
Inclusion Criteria:
- Paroxysmal atrial fibrillation despite of at least one Class I or Class III antiarrhythmic drug and/or previous conventional ablation (pulmonary vein isolation).
- At least one episode of paroxysmal atrial fibrillation should be documented by rhythm strip, ECG or implanted monitor during the last 6 months prior to ablation.
Exclusion Criteria:
- Significant structural heart disease (including symptomatic coronary heart disease; prosthetic mitral or tricuspid valve; congenital heart disease where abnormality or its correction prohibits or increases the risk of ablation).
- Intracardiac thrombus, tumor or dense contrast on TEE.
- Contraindication to anticoagulant therapy (heparin, warfarin, dabigatran and rivaroxaban).
- Anaphylactic allergy to contrast media.
- Poor general health resulting from other disease.
- Inability or refusal to provide written informed consent for the study.
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：なし
- 介入モデル：単一グループの割り当て
- 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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実験的：FIRM ablation
The first part of this within-patient trial investigate the efficacy of focal impulse and rotor modulation in 20 patients with paroxysmal atrial fibrillation, evaluated by continuous pre- and post-procedural heart rhythm monitoring. The second part consists of 20 patients with persistent or longstanding persistent atrial fibrillation following the same scheme. |
Radiofrequency catheter ablation of atrial fibrillation driving sources detected by sequential bi-atrial panoramic contact mapping.
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 |
|---|---|---|
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Single procedure freedom from atrial fibrillation (AF) at 12 months.
時間枠：12 months.
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Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
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12 months.
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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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Single procedure freedom from atrial fibrillation (AF) at 24 months.
時間枠：24 months.
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Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
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24 months.
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Single procedure freedom from atrial fibrillation (AF) at 30 months.
時間枠：30 months.
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Freedom from AF defined as <1% AF burden as detected by the implanted heart rhythm monitor.
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30 months.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cumulative freedom from atrial fibrillation (AF) (multi-procedure).
時間枠：30 months.
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Cumulative freedom from AF (multi-procedure) measured from final study.
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30 months.
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Major procedure related events.
時間枠：0 to 12 months.
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Cardiac tamponade/perforation; stroke; transient ischemic attack; bleeding; vascular access complications; injury to the esophagus/phrenic or vagal nerve etc.
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0 to 12 months.
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Number of rotors identified and percentage eliminated on remap.
時間枠：Procedural.
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Number of rotors identified and percentage eliminated on remap will be evaluated during the procedure.
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Procedural.
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Quality of life (QOL).
時間枠：12 months.
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QOL will be evaluated by the SF-36 health survey (Norwegian version) pre- and 12 months post ablation.
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12 months.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Rolf Franck Berntsen, MD, PhD、Dept. of Cardiology, Rikshospitalet - Oslo University Hospital
研究記録日
主要日程の研究
研究開始
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 (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
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。
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