Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification.
Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (PAF) [1]. However, the incidence of atrial fibrillation (AF) recurrence remains high [2], mostly due to pulmonary vein (PV) reconnection [1], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines [3].
Previous studies have shown that elimination of the negative component of the unipolar electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The persistence of such a negative component consistently corresponds to non-trans mural lesions [4].
調査の概要
詳細な説明
Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation procedures in patients with paroxysmal atrial fibrillation (PAF) [1]. However, the incidence of atrial fibrillation (AF) recurrence remains high [2], mostly due to pulmonary vein (PV) reconnection [1], emphasizing the formation of transmural lesions to achieve complete conduction block along the ablation lines [3].
Previous studies have shown that elimination of the negative component of the unipolar electrogram (UP-EGM) during radiofrequency applications reflects transmural lesions. The persistence of such a negative component consistently corresponds to non-trans mural lesions [4].
The high-power short duration (HPSD) RF application applies to all RF energies delivered at more than 40 W [5]. Higher the power more is the resistive heating causing wider tissue injury [5]. The lesion size with HPSD is larger in width but lesser in depth compared to lower powers with longer duration [5]. In contrast, RF applications of lower power and longer duration result in larger dissipation of RF energies deep into the tissues due to conductive heating causing tissue destruction at greater depths [6]. Hence, there is a risk of collateral tissue damage [5].
HPSD ablation has been advocated as a means to minimize the risk of collateral organ damage as the lesions are smaller in depth. However, Maintaining a high power for a constant duration in the absence of a guide may not be the right strategy [5].
Unipolar waveform modification by complete elimination of the negative component may serve as a guide for HPSD ablation [5].
研究の種類
入学 (予想される)
段階
- 適用できない
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
Exclusion Criteria:
- Age< 18 or > 80 years old,
- Atrium (LA) diameter > 50 mm,
- The presence of a mechanical mitral valve prosthesis,
- Left ventricular ejection fraction < 40%,
- Abnormal thyroid function,
- Contraindication to anticoagulant therapy,
- Current malignancy,
- Prior catheter or surgical AF ablation.
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：独身
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：Standard power application
|
Standard power application
|
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アクティブコンパレータ：High power application
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Radiofrequency delivery was performed in a point-by point fashion and continuously (an inter-lesion distance of 6 mm) with 50 W and 70 W and the ablation time for each point is limited to 7s and repeated if needed till the Unipolar signal modification turn to complete positive R wave.
|
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 |
|---|---|---|
|
Ablation success at 6-month after the index procedure
時間枠：6 months
|
Ablation success is defined as no recurrence with no anti-arrhythmic drugs by taking history of symptoms from the patient and by Holter 48 Hours.
|
6 months
|
協力者と研究者
スポンサー
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 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
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。
Standard power applicationの臨床試験
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Duke-NUS Graduate Medical SchoolSingapore General Hospital; Changi General Hospital; National Medical Research Council (NMRC),... と他の協力者完了
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University of Oxford完了
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Medical University of South CarolinaIcahn School of Medicine at Mount Sinai完了
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Tulane UniversityNational Institute of Mental Health (NIMH)完了
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VA Office of Research and Developmentまだ募集していません
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Centre Hospitalier Universitaire de Saint EtienneAssociation pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire完了