HeartR™ PDA Occluder Post-Market Follow-Up Study
The HeartR™ PDA Occluder Post-Market Clinical Follow-up (PMCF) Study is a multi-center, retrospective, single-arm study sponsored by Lifetech Scientific (Shenzhen) Co., Ltd., aiming to evaluate the long-term safety and performance of the Lifetech HeartR™ PDA Occluder in real-world clinical practice in Indonesia. A total of 140 subjects diagnosed with Patent Ductus Arteriosus (PDA) and treated with the HeartR™ PDA Occluder according to the Instructions for Use (IFU) will be enrolled.
Eligible subjects include patients aged ≥6 months, weighing ≥6 kg, with a PDA narrowest diameter ≥2 mm at the time of implantation. Patients without any follow-up visit after hospital discharge will be excluded from the study.
The primary endpoint is procedural success at 12 months post-implantation, defined as the absence of major adverse events including stroke/TIA, device embolization, cardiac or vascular perforation, left pulmonary artery stenosis or aortic stenosis requiring re-intervention, and procedure/device-related death, together with complete defect closure confirmed by Doppler echocardiography without residual shunt.
Secondary endpoints include complete closure rates before discharge and at 6 months post-implantation, incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention, incidence of device- or procedure-related adverse events (AEs) and serious adverse events (SAEs), as well as all-cause mortality through 24 months post-implantation.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Riau
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Pekanbaru, Riau, 인도네시아, 28156
- 모병
- RS Awal Bros
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연락하다:
- Shirley Leonita Anggriawan, Dr. Sp.A (K)
- 전화번호: 0761-47333
- 이메일: mkt.pku@awalbros.com
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수석 연구원:
- Shirley Leonita Anggriawan, Dr. Sp.A (K)
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) and were implanted with the HeartR™ PDA Occluder as per IFU instructions
- Age ≥ 6 months at the time of implantation.
- Weighing ≥ 6 kg at the time of implantation.
- Narrowest portion of the PDA ≥ 2mm at the time of implantation.
Exclusion Criteria:
Patients did not conduct any follow up visit after hospital discharge.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Procedural success
기간: 12 months post-implantation
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12 months post-implantation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Complete closure of the defects with no residual shunt
기간: before discharge and at 6 months post-implantation
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Complete closure of the defects with no residual shunt
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before discharge and at 6 months post-implantation
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Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
기간: before discharge and at 6 months, 12 months post-implantation
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Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
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before discharge and at 6 months, 12 months post-implantation
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Incidence of device or procedure related Adverse Events (AEs)
기간: from attempted procedure to 24 months post-implantation
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Incidence of device or procedure related Adverse Events (AEs)
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from attempted procedure to 24 months post-implantation
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Incidence of device or procedure related Serious Adverse Events (SAEs)
기간: from attempted procedure to 24 months post-implantation
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Incidence of device or procedure related Serious Adverse Events (SAEs)
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from attempted procedure to 24 months post-implantation
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Incidence of death
기간: from attempted procedure to 24 months post-implantation
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Incidence of death
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from attempted procedure to 24 months post-implantation
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공동 작업자 및 조사자
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- LT-TS-2-2025-01
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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