ポイントアブレーションカテーテルからのパルスフィールドアブレーションを使用した局所性心室頻拍の治療 短いタイトル FOCUS-PFA (FOCUS PFA)
The purpose of this study is to examine the use of a point ablation catheter (Farapoint, Boston Scientific) in the mapping and ablation of focal ventricular arrhythmias (premature ventricular contractions or ventricular tachycardia) using pulsed field energy.
調査の概要
詳細な説明
Study Design - This is a prospective, single-center, single-arm clinical pilot study to assess the safety and effectiveness of ablation of focal ventricular arrhythmias using the Farapoint catheter.
Sample Size - A total of 60 subjects will be included in this study. All patients will undergo treatment with the study PFA catheter.
Study Population - The target population is subjects who are planned to undergo a clinically-indicated ablation procedure for managing their focal ventricular arrhythmias - premature ventricular contractions or ventricular tachycardias.
Study Duration - Approximately 12 months: 3 months site start-up, 6 months enrollment and 3 months of follow up.
Participant Duration - Subjects will undergo brief pre-procedural testing, the ablation procedure, and 3 months of post-procedural follow up.
Primary Effectiveness Endpoint Chronic Single-Procedure Success: defined as a reduction in the burden of premature ventricular contracts (>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups.
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
-
-
New York
-
New York、New York、アメリカ、10029
- Icahn School of Medicine at Mount Sinai
-
-
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:
Subjects must meet ALL of the following inclusion criteria to be eligible for participation in this clinical investigation:
-
Patient is planned for a catheter ablation procedure to ablate either:
- Premature ventricular contractions (PVCs) and a class I or IIa indication for catheter ablation of PVCS according to the 2019 HRS/EHRA/APHRS/LAHRS guidelines
- Symptomatic Sustained Monomorphic Ventricular Tachycardia
-
Able and willing to provide written consent and comply with all testing and follow-up requirements
-
Above 18 years of age
Exclusion Criteria:
- Documented intracardiac thrombus or (if this can be dissolved with anticoagulation, the patient would then be eligible to participate)
- Contraindication to anticoagulation
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
- Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
- NYHA Class IV heart failure
- Severe, untreated coronary artery disease which would preclude infusion of provocative agents
- Severe aortic stenosis (AVA < 1.0cm, or PG > 64mmHg)
- Severe mitral regurgitation.
- Allergy to contrast which is unable to be adequately pre-medicated.
- Acute non-cardiovascular illness or systemic infection
- Thrombocytopenia (platelet count < 50,000/mm3) or coagulopathy unless corrected
- Cardiogenic shock unrelated to ventricular arrhythmias
- Pregnancy or anticipated pregnancy during study follow-up
- PVCs or VT, which are felt to be secondary to electrolyte imbalances active thyroid disease or any reversible non-cardiac cause.
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 |
|---|---|
|
実験的：Ablation using study catheter
All patients will undergo a standard ablation protocol using the study catheter (Farapoint) |
a point ablation catheter using a pulse field energy
他の名前：
|
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 PVC/VT recurrence
時間枠：at 3 months following ablation procedure
|
Freedom from PVC/VT recurrence defined as a reduction in the burden of premature ventricular contracts (>80%) for patients treated for PVCs or absence of sustained focal ventricular tachycardia for patients being treated for focal VTs without an increase in anti-arrhythmic medications at 3 month follow ups. (Sustained Focal Tachycardia is defined as that persisting for > 30 seconds or ventricular tachycardia which is sufficient to result in hemodynamic effect (i.e. hypotension or syncope)) |
at 3 months following ablation procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Adverse events
時間枠：at 3 months following ablation procedure
|
Safety is measured as incidence of Serious Adverse Device Effects (SADEs) |
at 3 months following ablation procedure
|
|
Incidence of Serious Adverse Events (SAEs)
時間枠：at 3 months following ablation procedure
|
Safety is measured as incidence of Serious Adverse Events (SAEs) |
at 3 months following ablation procedure
|
|
Incidence of non-serious adverse events
時間枠：at 3 months following ablation procedure
|
Safety is measured as incidence of non-serious adverse events |
at 3 months following ablation procedure
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Vivek Reddy, MD、Icahn School of Medicine at Mount Sinai
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
その他の研究ID番号
- STUDY-24-00971
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
米国で製造され、米国から輸出された製品。
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