"EASE" Epicardial Access With the EpiAccess System (EASE2)
EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.
연구 개요
상세 설명
Prior to enrolment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be enrolled in the study by the local principal investigator after informed consent is obtained.
As EpiAccess is only used for the access portion of electrophysiology procedures, the safety, performance and effectiveness endpoints are acute from the time of needle insertion to pericardial space access (guidewire insertion into the pericardial sac). Patients will be followed until hospital discharge. Follow-up clinical examinations will be performed in accordance with institutions' standard of care. No special tests are required for this device. Patients' completion of study will occur at the time of their hospital discharge, or earlier if patient did not complete the study.
The stop criterion for this study is: greater than 25% Serious Adverse Device Effect, as defined in this protocol, after enrolment of 10 or more patients, compared to existing data from the literature presenting epicardial access procedure results during sub-xyphoid (minimally invasive) surgical procedures.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Prague, 체코 공화국
- Nemocnice Na Homolka
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient is 18 years of age or older
- Pericardial access is clinically indicated
- Patient is willing and able to provide written informed consent
Exclusion Criteria:
- Patient with history of cardiac or pericardial surgery in the past 6 months
- Patient with history of chronic pericarditis
- Myocardial infarction within 4 weeks prior to procedure
- Class IV NYHA (New York Heart Association) heart failure symptoms
- Cerebrovascular accident within previous 6 months
- Known carotid artery stenosis greater than 80%
- Presence of thrombus in the left atrium
- Coagulopathy
- Severe Hepatic Dysfunction or Enlargement
- Life expectancy less than 6 months
- BMI > 40
- Patient is enrolled in another clinical trial
- Patient is pregnant
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: EpiAccess
EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
|
Access to the pericardium to enable further treatments.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
기간: Through discharge / approx 4 days
|
EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved.
The percentage of patients in whom pericardial access was successful will be reported.
|
Through discharge / approx 4 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System
기간: access through procedure completion
|
EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.
|
access through procedure completion
|
|
Percentage of Participants With a Pericardial Effusion of >80ml
기간: Access through discharge/approximately 4 days
|
Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.
|
Access through discharge/approximately 4 days
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System
기간: Access through end of procedure
|
Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey
|
Access through end of procedure
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Andrea Natale, MD, University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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 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. .
부정맥, 심장에 대한 임상 시험
-
Near East University, TurkeyAl-Ahli Hospital, Hebron모집하지 않고 적극적으로DVT 예방 | DVT - 심부 정맥 혈전증 | 심장 온펌프 수술 | DVT 예방 | On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications | 간호 관리 프로토콜키프로스
Pericardial access에 대한 임상 시험
-
Beckman Coulter, Inc.완전한
-
Hugo W. Moser Research Institute at Kennedy Krieger...완전한
-
Memorial Sloan Kettering Cancer Center모병
-
Lawson Health Research InstituteBoston Scientific Corporation종료됨
-
University of North Carolina, GreensboroInstitute of Education Sciences완전한주의 결핍 과잉 행동 장애
-
GE Healthcare완전한