A Prospective, Randomized, Blind, Controlled Multicenter Clinical Study Comparing the Effectiveness of Preventive Ventricular Arrhythmia Ablation on the Prognosis After Left Ventricular Assist Device (LVAD) Surgery. (PAVA-LVAD)
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Anhui
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Hefei, Anhui, 중국
- 5thBuilding, 9thFloor, High-tech Campus of the First Affiliated Hospital of Anhui Medical University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 1.voluntary and with the provision of an informed consent form 2.males or females aged 18 years or older 3.all patients with acute and critical or chronic advanced heart failure who have failed to respond to standardized oral medication and are scheduled to undergo artificial heart implantation surgery
Exclusion Criteria:
1.The left ventricular assist system is prohibited for patients who cannot tolerate anticoagulant therapy or who are allergic to anticoagulant treatment.
2.Doctors with sufficient experience will make a comprehensive judgment based on the patient's physical condition, body surface area, and the anatomical-related conditions of the planned implantation site, and determine those who are not suitable for the implantation procedure.
3.Pregnant women. 4.Systemic active infection. 5.Patients in a state of brain death. 6.Irreversible severe liver or kidney dysfunction. 7.Having a history of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease.
8.primary pulmonary hypertension. 9.Having a confirmed and untreated history of abdominal or thoracic aortic aneurysm with a diameter greater than 5 cm.
10.Patients with severe atherosclerotic plaques in the aorta. 11.Having mental disorders/impairments, irreversible cognitive dysfunction, or social-psychological problems, which makes it possible for the patient to fail to comply with the application management regulations of the implanted left ventricular assist device.
12.Preoperative conditions included end-stage organ failure, such as renal failure (requiring hemodialysis), liver failure, respiratory failure; and concurrent malignant tumors or any severe accompanying diseases with an expected lifespan of less than 3 years.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: preventive ablation group
for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
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for patients undergoing LVAD surgery while also undergoing prophylactic ablation of ventricular arrhythmias at the same time
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간섭 없음: the control group without any treatment
no intervention measures
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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persistent ventricular tachycardia / ventricular fibrillation
기간: Continuous electrocardiogram monitoring for 30 days after surgery
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Electrocardiogram monitoring was conducted daily for the patients 30 days after the surgery.
Data were uploaded daily and the frequency of arrhythmia occurrences was statistically analyzed.
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Continuous electrocardiogram monitoring for 30 days after surgery
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all-cause mortality
기간: Within 30 days after the operation
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Conduct a 30-day follow-up visit for the patients, and collect the time and cause of death.
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Within 30 days after the operation
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mechanical thrombus
기간: Within 30 days after the operation
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Electrocardiogram monitoring was performed daily on the patients 30 days after the surgery.
When thrombosis occurred, the left heart assist device would give an alarm to alert.
In some cases, autopsy could be conducted to obtain the results.
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Within 30 days after the operation
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right heart failure
기간: Within 30 days after the operation
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Conduct a 30-day follow-up visit for the patients, and collect the time and cause of right heart failure.
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Within 30 days after the operation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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all-cause mortality
기간: semi-annually, for a total of three years
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Patients are followed up in the outpatient department or by phone every six months to collect death-related records such as death certificates and discharge summaries.
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semi-annually, for a total of three years
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mechanical thrombus
기간: semi-annually, for a total of three years
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The artificial heart device implanted in the patient will continuously monitor.
When a thrombosis occurs, the left heart assist device will alert and remotely contact the medical team.
In some cases, this information can be obtained through autopsy after death.
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semi-annually, for a total of three years
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stroke
기간: semi-annually, for a total of three years
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Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records, imaging reports (such as head CT or MRI), and other original materials are collected.
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semi-annually, for a total of three years
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Hospitalization or emergency visit due to heart failure
기간: semi-annually, for a total of three years
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Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records are collected, including symptoms such as shortness of breath and signs such as lower extremity edema, measurement of brain natriuretic peptide levels, and treatment with diuretics, etc.
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semi-annually, for a total of three years
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heart transplantation
기간: semi-annually, for a total of three years
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Patients are followed up in the outpatient department or by phone every six months, and the necessary medical history records are collected.
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semi-annually, for a total of three years
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공동 작업자 및 조사자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 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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