ハミングバードICE研究
The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of the VeriSight Pro imaging platform.
調査の概要
詳細な説明
This is a prospective, multi-center, open label, observational registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted under the approval of one or more recognized institutional review boards and in compliance with Good Clinical Practice guidelines defined in International Standards Organization:14155;2011, the Declaration of Helsinki, and all applicable federal and local laws and regulations.
VeriSight Pro catheter is for use with Philips EPIQ series of ultrasound system. VeriSight Pro is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The catheter is intended for imaging guidance only during cardiac interventional percutaneous procedures and structural heart procedures. A detailed description of VeriSight can be found in the products' IFU.
Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. The objective of the study is to collect a comprehensive dataset of raw, de-identified native un-processed ultrasound images and where available collect associated fluoroscopic, CT and MRI images, demographic information and procedural parameters when VeriSight Pro is used in routine percutaneous cardiac intervention procedures and/or ablation procedures. Collected data will be used for development efforts aimed at optimizing image quality, image processing and interoperability of VeriSight Pro imaging platform.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Clinical Study Manager
- 電話番号：1 774 249 6135
- メール：phil.parthree@philips.com
研究連絡先のバックアップ
- 名前：Ali Kolste
- メール：ali.kolste@philips.com
研究場所
-
-
Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Hospital
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コンタクト：
- Veronica Gordon
- 電話番号：313-949-2431
- メール：vgorden1@hfhs.org
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主任研究者：
- Georgi Fram, MD, FACC FASE
-
-
New Jersey
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Camden、New Jersey、アメリカ、08103
- Cooper Hospital
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コンタクト：
- Erin Siderio
- 電話番号：856-582-2000
- メール：esiderio@hearthousenj.com
-
主任研究者：
- John Costello, D.O.
-
-
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
サンプリング方法
調査対象母集団
All subjects age 18 and older that are scheduled for and will undergo a planned cardiac interventional percutaneous procedure in which the guidance of ICE is indicated, eligible and willing to sign an informed consent without meeting any of the exclusion criteria set and meeting all the inclusion criteria set forth in the protocol will be included in the population for analyses.
説明
Inclusion Criteria:
- 18 years of age
- Willing to provide written, dated and signed, informed consent
- Undergoing percutaneous cardiac intervention procedures in with VeriSight Pro is used
Exclusion Criteria:
- Contraindicated for ICE catheter placement or considerations that make placement of VeriSight not technically feasible
- Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease
- Pregnancy
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
- 観測モデル：CASE_ONLY
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Prospective Observational
Prospective observational subjects undergoing planned cardiac procedures utilizing VeriSight image guidance |
VeriSight PRO ICE image guidance
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 |
|---|---|---|
|
Major procedural complication rate [Safety and Tolerability]
時間枠：During procedure
|
Major procedural complication rate (Cardiac perforation, pericardial tamponade, pericardial effusion requiring intervention, major vascular complication requiring intervention or transfusion, procedural related stroke, death or device embolization) related to the device (Verisight Pro) |
During procedure
|
|
Effectiveness (Technical Success)
時間枠：During procedure
|
Technical success of VeriSight Pro is defined as: Successful guidance of the treating device to the intended target region, and generation of intracardiac images adequate to visualize the target anatomy relevant to the planned intervention. Technical success is assessed by the Investigator or qualified designee at procedure end. |
During procedure
|
協力者と研究者
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SEF-2025-301281
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?
IPD プランの説明
Individual participant data does not need to be shared to meet study objectives.
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。
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。