- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02764645
Performance of the CARDIOGARD Cannula (GECG)
A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula
This is a single center, prospective study:
The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.
연구 개요
상세 설명
Patients referred for CPB procedure will be offered to participate in the study. Patients will be asked to sign an informed consent form (ICF), prior to performing any study related procedures.
The point of enrollment is the time at which a patient signs and dates the ICF. Following enrollment, the patient will undergo screening evaluation (including Neurological assessment) to determine eligibility. Screening failures will be identified on a screening log. Patients who are found to meet all inclusion criteria and none of the exclusion criteria will compose the evaluable cohort of the study. Screening failure subjects will not be counted as part of the target patient sample size nor will they be included in the analysis.
Patients in the randomized phase will have surgery with the CardioGard Cannula or comparator cannulae and will remain blinded to their group assignment through the 30 days follow-up evaluation.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Roi - Glam, MD
- 전화번호: +972-4-7772631
- 이메일: r_glam@rambam.health.gov.il
연구 연락처 백업
- 이름: Daniel - Haber, MA
- 전화번호: +972-4-7772048
- 이메일: d_haber@rambam.health.gov.il
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient indicated for first-time non-emergent procedure under cardiopulmonary bypass which is expected to last up to 6 hours.
- Patient undergoing an elective isolated coronary artery bypass surgery (CABG), or an elective isolated aortic/mitral valve replacement (AVR/MVR) or an elective combined aortic/mitral valve replacement (AVR/MVR) with coronary artery bypass surgery (CABG).
- The patient is >50 and <85 years of age.
- The patient's body weight is compatible with blood net flow of 4 - 5 [l/min].
- Patient with left ventricular ejection fraction >30% as assessed by either echocardiography, angiography or by radio nuclear assessment (MUGA)
- The patient is willing to participate as evidenced by signing the written informed consent.
- Male or non-pregnant female patient (Note: Females of child bearing potential must have a negative pregnancy test)
Exclusion Criteria:
- Patient with abnormal clotting mechanism: PT 60%, PTT>2 the normal.
- Patient with an aortic trauma.
- Patient contraindicated for open heart surgery under bypass machine.
- Patient undergoing a re-do procedure.
- Patient intended for an operation performed using minimally invasive surgical techniques (e.g., mini-sternotomy)
- Patient with pathologies which affect his/her neurological condition.
- Patient in whom emergency operation is required.
- Patient with a known allergy to Heparin
Patient with major co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study, including but not limited to:
- previous stroke
- critical preoperative state
- poor ventricular function
- severe pulmonary hypertension [19]
- Atheroembolism
- history of cardiac failure [20]
- Current use of drugs that might result in high surgical risk or significant postoperative complication.
- Psychological instability, inappropriate attitude or motivation.
- Patients with life threatening debilitating disease other than cardiac.
- Subjects currently enrolled in another investigational device or drug trial that has not completed the primary end point or that clinically interferes with the current study endpoints.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: CardioGard group
Patients in whom the CardioGard Cannula will be used, while In these patients there would be a measurement of the gaseous emboli in two points: 1. The aortic vent. 2. The suction cannula of the 'Cardiogard cannula'. |
CardioGard Cannula is a specially designed arterial (aortic) cannula for use in cardiac surgery for the purpose of removal of gaseous and solid embolic material emanating during the CPB procedure. The CardioGard cannula is a double lumen cannula where the primary lumen provides blood from the heart-lung machine similar to ordinary cannulas and the secondary lumen performs suction of blood and embolic matter away from the aortic arch and back to the cardiopulmonary bypass machine for filtration. |
활성 비교기: Control group
Patients in whom a 22Fr curved Cannula will be used, while In these patients there would be a measurement of the gaseous emboli in the aortic vent alone.
|
arterial cannula for use in cardiac surgery
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The 'CardioGard Cannula' Gaseous emboli capturing ability
기간: 36 months
|
The gaseous emboli capturing ability of the cardiogard cannula will be evaluated using a bubbles counter. .
|
36 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
The amount of emboli particles which evacuated from the cardiopulmonarybypass machine by the CardioGard Cannula
기간: 36 months
|
Using the suction feature, External filters will be analyzed in order to recover particulate matter.
|
36 months
|
The Neurological effect of reducing gaseous emboli from the heart during cardiac surgery.
기간: 36 months
|
The ability of the Cardiogard cannula will be evaluated using Neurological questionnaires.
|
36 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Gil - Bolotin, Prof., Head of the Cardiac Surgery Department, Rambam Health Care Campus
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CLNG100 Full Protocol
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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