フィリップス心臓内心エコー検査 (ICE) 臨床登録
Philips (VeriSight) 心内心エコー検査 (ICE) レジストリ
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
調査の概要
詳細な説明
This is a prospective, multi-center, observational, single-arm registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted in the United States 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. Only on label uses of the VeriSight ICE catheter will be allowed. No specific claims are being validated during this registry, though data analyzed from this protocol are intended to inform of future claims regarding the performance and safety of the VeriSight catheter.
Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. Enrolled subjects will be followed until discharge or ≤48 hrs post-procedure. The registry has a planned duration of approximately 24-36 months with interim analysis planned at 100 patients before further enrollment will be considered. Statistical hypotheses are not intended for this registry and descriptive analysis will be conducted. Data from all clinical sites are intended to be pooled for analysis. It is possible that sub-analyses may be conducted to demonstrate VeriSight guidance for target intervention types in structural heart and electrophysiology procedures.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Colorado
-
Aurora、Colorado、アメリカ、80045
- University of Colorado
-
-
Illinois
-
Chicago、Illinois、アメリカ、60208
- Northwestern University
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
-
-
Texas
-
Austin、Texas、アメリカ、78705
- Texas Cardiac Arrhythmia Research Foundation
-
-
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 and willing to provide written, dated and signed, informed consent
- Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU)
Exclusion Criteria:
- Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible
- If alternate access (as needed instead of femoral) is not viable
- 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.
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 image guidance |
ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures
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 |
|---|---|---|
|
Technical Success
時間枠：During procedure
|
Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure |
During procedure
|
|
Imaging Success
時間枠：During procedure
|
Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator |
During procedure
|
|
Clinical Success
時間枠：During procedure
|
Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications. |
During procedure
|
|
Number of Participants With Device-related Adverse Event Detection
時間枠：Procedure through 48 hours or discharge, whichever is earlier
|
Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier. |
Procedure through 48 hours or discharge, whichever is earlier
|
協力者と研究者
捜査官
- スタディディレクター：Rashmi Ram, PhD、Philips Clinical and Medical Affairs
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 (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
追加の関連 MeSH 用語
その他の研究ID番号
- 2019_10745
- 2019 (米国 NIH グラント/契約)
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。
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。