The ShortCut Post-Market Study (ShortCut PMS)
A Prospective, Multicenter, Non-Randomized, Single-Arm, Post-Market Study of the ShortCut™ (The ShortCut PMS)
This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for subjects at risk for coronary obstruction. The ShortCut has been cleared by FDA under DEN240017, and this study is a post-market evaluation of the ShortCut per the FDA cleared indications for use.
The objectives of the study are:
- To collect real-world data on the use of ShortCut to split bioprosthetic aortic valve leaflets prior to TAVR in subjects at risk for coronary obstruction.
- To collect real-world data on coronary patency following ShortCut and ViV TAVR procedures in subjects who are at risk for coronary artery ostium obstruction.
Data will be collected, where available, from the subjects' medical records at the following time-points: baseline, index procedure, pre-discharge, and 30 days post-procedure.
연구 개요
상태
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Male or female ≥ 22 years of age.
- Subject is planned to undergo a ViV TAVR procedure with the ShortCut, according to its labeling.
- Preprocedural evidence for risk for coronary occlusion during ViV TAVR in bioprosthetic valve failure.
- Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations
Exclusion Criteria:
- Any contraindication as specified in the approved device label.
- An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.
- Anatomy that is not suitable for the use of the ShortCut, as determined by CT assessment.
- Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure.
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure or severe neurological disability, as determined by the investigator.
- Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- Hemodynamic or respiratory instability.
- Left ventricle ejection fraction < 30%.
- Ongoing severe infection, sepsis or endocarditis.
- Patient has renal insufficiency (GFR < 30 ml/min or serum creatinine > 2.5 mg/dL), or on chronic dialysis.
- Need for emergency surgery for any reason.
- Life expectancy is less than 1 year.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Primary Safety Assessment
기간: At discharge or 7 days post-procedure, whichever occurs first
|
Each of the following ShortCut- and/or ShortCut procedure-related adverse events at initial cardiac hospitalization discharge or 7 days post-procedure, whichever occurs first, as assessed by the Clinical Events Committee (CEC):
|
At discharge or 7 days post-procedure, whichever occurs first
|
|
Primary Effectiveness Assessment
기간: Immediately after TAVR procedure
|
Rate of coronary patency of the coronary ostium adjacent to the treated leaflet by contrast aortography after TAVR implantation as assessed by a core lab.
|
Immediately after TAVR procedure
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CLN-0003581
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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