- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01270646
Impact of Intraventricular Electrical Activation in Resynchronization Therapy (CARTO-CRT)
Study of the Role of Intraventricular Electrical Activation in the Treatment of Congestive Heart Failure by Cardiac Resynchronization Therapy: Invasive Evaluation and Validation of Non-Invasive Strategy Using CardioInsight ®
연구 개요
상태
상세 설명
Comprehensive study, prospective, monocentric and cohort study.
Biventricular pacing is an effective therapy to improve end stage heart failure patients, however up to 30% of patients are unresponsive to this therapy. Among others, optimization of Left Ventricle (LV) pacing site location is critical to optimize response to Cardiac Resynchronization Therapy (CRT). Whether a better comprehension of baseline LV electrical activation can help to determine optimal LV lead location remains to be investigated.
After informed consent patients are included in the sudy. Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the LV cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Quantitative parameters: Global LV activation time (LVATG) (primary outcome); septal activation time (LVTAS); Global intra-LV dispersion time and Qualitative parameters: presence of intraLV line of block, area of late activation. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping. A 3 and 6 months follow-up visit including clinical, biological evaluation (NYHA status, 6-min walking test, BNP) of the patients will be performed with an additional transthoracic echocardiography at 6 months.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
-
Pessac, 프랑스, 33604
- Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult (aged 18 or above)
- Sinus rhythm
- Patient must have signed informed consent
- Cardiac insufficiency of whatever cause (ischemic or non-ischemic)
- Patient eligible for implantation of a ventricular resynchronization device or patient with a ventricular resynchronization device having a procedure of ventricular tachycardia ablation
- Left ventricular ejection fraction <35%
- NYHA Class II to IV with optimal medical treatment
- Patient covered by national healthcare insurance
Exclusion Criteria:
- Pregnant woman
- Sequel of transmural myocardial infarction
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intraventricular Electrical Activation
|
Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the Left Ventricle (LV) cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Evolution of the Global Left Ventricle activation time (LVATG) with and without Cardiac Resynchronization Therapy (CRT).
기간: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Number, area and location of line of conduction block in the Left Ventricle
기간: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
|
Area of the latest activated region of the Left Ventricle
기간: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
|
Number, area and location of LV region activated after the end of surface QRS
기간: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
|
Septal activation time (LVTAS)
기간: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
|
Global intra-Left Ventricular dispersion time
기간: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
|
Determination of the electrical parameters associated with good clinical response to CRT at 6 months.
기간: 6 months after CRT device implantation
|
6 months after CRT device implantation
|
|
Non-invasive mapping: Same criteria evaluated non-invasively using CardioInsight ® with and without Cardiac Resynchronization Therapy activated.
기간: Between 3 to 7 days after CRT device implantation
|
Between 3 to 7 days after CRT device implantation
|
공동 작업자 및 조사자
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. .