CardioGenesis Transmyocardial Revascularization 1-Year Follow-Up Study
2021년 3월 3일 업데이트: CryoLife, Inc.
A Multi-Center Single Arm One Year Prospective Follow-Up of Patients Treated With the CryoLife CardioGenesis Holmium:YAG Laser System for Transmyocardial Revascularization (The TMR 365 Study)
The purpose of this study it to collect real world 30-day and 1-year follow-up data for patients undergoing TMR with the CardioGenesis Holmium:YAG Laser System either as a sole therapy procedure or in conjunction with coronary artery bypass graft (CABG) surgery.
The primary objective of this study is to provide ongoing clinical data regarding the characteristics of the patient population undergoing TMR in community practices. Secondary objectives include rates of postoperative mortality and MACE at 30-days and 1-year, and benefit of sustained improvement in angina at 30-days and 1-year.
The study includes two patient populations:
- Registry Group: Patients from selected centers who previously participated in the ANGINA RELIEF Registry and are eligible for a one-year, prospective follow-up;
- Prospective Group: Up to 100 new, prospectively enrolled TMR patients from selected centers.
연구 개요
상태
완전한
정황
상세 설명
The study objectives are as follows:
- Track "real world" performance outcomes and physician experience using the CardioGenesis Laser System;
- Further define the disease characteristics of the population being treated;
- Examine transmyocardial revascularization (TMR) usage characteristics, including surgical procedure information, and 30-day and 1-year outcomes;
- Further assess the risk factors for adverse events at 30-days and 1-year;
- Further define MACE rates and angina scores at 30-days and 1-year. To limit the potential for bias, all patients eligible for TMR treatment who meet the Inclusion and Exclusion Criteria will be offered the opportunity to enroll in the study at participating centers.
Primary Endpoint:
- 1-year Canadian Cardiovascular Society (CCS) angina class
Secondary Endpoints:
- All-cause mortality at 30-day and 1-year.
- Rates of major adverse cardiovascular events (MACE) at 30-days and 1-year, defined as the incidence of cardiac-related death, myocardial infarction (Q-wave and non Q-wave), congestive heart failure, cerebrovascular accident, and serious arrhythmia.
The definitions for MACE events are as follows:
- Cardiac-related death: any death that is not clearly attributable to a non-cardiac cause, and includes death due to any of the following: acute myocardial infarction, heart failure, cardiogenic shock, pulmonary edema, cardiac tamponade, arrhythmia, or post-procedural complications (i.e., bleeding).
- Q-wave myocardial infarction: the appearance of new Q waves of 40 or more milliseconds in 2 or more contiguous leads and elevation of CK-MB.
- Non Q-wave myocardial infarction: the elevation of total CK more than twice normal with elevated CK-MB.
- Congestive heart failure: Symptoms of pulmonary vascular congestion or a low output state that is due to left ventricular failure and is new in onset or results in re-hospitalization.
- Cerebrovascular accident: Any sudden development of neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, or thrombosis that persists for > 24 hours.
- Serious arrhythmia: Supra-ventricular or ventricular arrhythmias that require sustained intravenous pharmacologic treatment, temporary or permanent pacing, or immediate electrical cardioversion or defibrillation. Arrhythmias resulting in syncope, myocardial ischemia, or death are also classified as serious.
- Any other serious operative complications related to the procedure: example: major bleeding requiring transfusion.
연구 유형
관찰
등록 (실제)
114
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Florida
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Jacksonville, Florida, 미국, 32204
- Cardiothoracic and Vascular Surgical Associates
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Tennessee
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Nashville, Tennessee, 미국, 37203
- TriStar Cardiovascular Surgery
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
All patients who meet the eligibility criteria at the selected centers will be provided an opportunity to participate.
설명
Inclusion Criteria:
- Registry Group: Previously enrolled in the ANGINA RELIEF Registry; Eligible for a 1-year prospective follow-up (date of TMR procedure performed within 12-18 month follow-up window).
- Prospective Group: Received TMR with the CardioGenesis Laser System; Class IV angina (according to Canadian Cardiovascular Society Angina Scale) prior to TMR; Patients with regions of myocardium in the distal two-thirds of the left ventricle with reversible ischemia and who are not eligible for direct coronary revascularization (e.g., CABG or PTCA).
Exclusion Criteria:
- Registry Group: Date of ANGINA RELIEF Registry TMR procedure performed outside 1-year (12-18 month) follow-up window.
- Prospective Group: Age less than 18 years; Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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Registry Group
Patients previously enrolled in the ANGINA RELIEF Registry who are eligible for a 1-year, prospective follow-up (date of ANGINA RELIEF Registry TMR procedure performed within 12-18 month follow-up window).
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Prospective Group
A group of up to 100 new, prospectively enrolled patients from active centers that receive TMR with the CardioGenesis Laser System and complete a 30-day and 1-year follow-up.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Canadian Cardiovascular Society (CCS) Angina Class from Baseline (Class IV) at 1 Year.
기간: 1 year
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Class I: Ordinary physical activity does not cause angina, such as walking and climbing stairs.
Angina with strenuous or rapid or prolonged exertion at work or recreation; Class II: Slight limitation of ordinary activity.
Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening.
Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions; Class III: Marked limitation of ordinary physical activity.
Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace; Class IV: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of all cause mortality
기간: 30 days, 1 year
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All-cause mortality
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30 days, 1 year
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Rates of Major Adverse Cardiovascular Events (MACE)
기간: 30 days, 1 year
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Defined as the incidence of cardiac-related death, myocardial infarction (Q-wave and non Q-wave), congestive heart failure, cerebrovascular accident, and serious arrhythmia.
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30 days, 1 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 3월 1일
기본 완료 (실제)
2020년 10월 1일
연구 완료 (실제)
2020년 10월 1일
연구 등록 날짜
최초 제출
2016년 2월 22일
QC 기준을 충족하는 최초 제출
2016년 2월 24일
처음 게시됨 (추정)
2016년 3월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 3월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 3월 3일
마지막으로 확인됨
2021년 3월 1일
추가 정보
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