Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction (PAST-HFrEF)
2026년 9월 9일 업데이트: Guangyuan Song, Beijing Anzhen Hospital
A Prospective, Randomized, Open-Label, Parallel-Controlled, Superiority, Multicenter Clinical Study of Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction
To evaluate the safety and effectiveness of the Atrial Shunt for the treatment of heart failure with reduced ejection fraction (HFrEF)
연구 개요
상태
모병
상세 설명
This is a prospective, randomized, open-label, parallel-controlled, superiority, multicenter clinical study. A total of 208 subjects will be randomized 1:1 after meeting all inclusion/exclusion criteria.
Treatment Group: atrial shunt implantation post-right heart catheterization. Control Group: Right heart catheterization only. Both groups will receive standardized Guideline-Directed Medical Therapy (GDMT) post-procedure. Assessments and follow-ups will be conducted at pre-procedure baseline, day of procedure, 1 week, 1 month, 3 months, 6 months, and 12 months post-procedure.
A Clinical Event Committee (CEC), composed of third-party cardiovascular experts, will independently review and adjudicate primary endpoints in a blinded manner (surgical information concealed).
연구 유형
중재적
등록 (추정된)
208
단계
- 2 단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sanshuai Chang, M.D.
- 전화번호: +8618501369869
- 이메일: 18501369869@163.com
연구 연락처 백업
- 이름: Guangyuan Song, M.D.
- 전화번호: +8613801120805
- 이메일: songgy_anzhen@vip.163.com
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100029
- 모병
- Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
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연락하다:
- Sanshuai Chang, M.D.
- 전화번호: +8618501369869
- 이메일: 18501369869@163.com
-
-
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 1. Age ≥ 18 years 2. Diagnosed with HFrEF and receiving Guideline-Directed Medical Therapy (GDMT) for at least 1 month 3. Echocardiographic LVEF between 20% and 40% (20 ≤ LVEF ≤ 40%) 4. Presence of HF-related symptoms and signs, NYHA Class III 5. At least one HF-related hospitalization in the past year or NT-proBNP ≥ 600 pg/mL (sinus rhythm) / ≥ 1000 pg/mL (atrial fibrillation) 6. Invasive hemodynamics: mLAP or mPCWP ≥ 15 mmHg, or left-to-right mean pressure gradient ≥ 5 mmHg 7. Fully understand the study design and follow-up schedule, agrees to participate, and voluntarily signs the Informed Consent Form
Exclusion Criteria:
- 1. End-stage heart failure on the heart transplant waiting list (including meeting LVAD indications) 2. Three consecutive non-invasive systolic blood pressure readings < 90 mmHg 3. Primary structural valvular disease currently indicating surgery or interventional therapy, or severe coronary artery disease requiring revascularization 4. ECG QRS duration ≥ 130 ms with high risk of sudden cardiac death without therapeutic intervention (including meeting CRT/CRT-D indications) 5. Significant right ventricular (RV) dysfunction or severe pulmonary hypertension. Defined by clinical evidence of hepatic congestion, moderate-to-severe edema, or abdominal distension accompanied by poor appetite; significant right atrial or RV enlargement/dysfunction; moderate-to-severe tricuspid regurgitation; mean right atrial pressure > 10 mmHg; systolic pulmonary artery pressure > 60 mmHg; or pulmonary vascular resistance > 3 Wood Units 6. Myocardial infarction or cardiac intervention within the past 1 month 7. Stroke within the past 1 month (excluding lacunar infarction) 8. Decompensated liver cirrhosis (Child-Pugh Class B or worse), or severe chronic pulmonary disease requiring oxygen therapy 9. Anatomical abnormalities precluding procedure completion or making the patient unsuitable for procedure 10. Atrial thrombosis 11. Contraindication to antithrombotic therapy 12. Life expectancy < 1 year 13. Uncontrolled active infection 14. Pregnant, lactating, or women of childbearing potential planning pregnancy in the near future 15. Currently participating in another drug or medical device clinical trial 16. Investigator deems the patient unsuitable for this trial
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Device group (Interventional group)
Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease
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The D-Shant atrial shunt device is a novel device therapy for heart failure, classified as a non-active implantable cardiovascular device.
It is manufactured using a braided Nitinol technique, thermally set via assembly molds to form a waist with a fixed-orifice support and a hollow double-disc structure.
Braided wires reinforce waist support and maintain a circular orifice shape.
Once implanted, it forms a stable interatrial shunt.
The device is delivered via the femoral vein to the interatrial septum, where the shunt orifice facilitates blood flow diversion and pressure decompression.
Various models with different waist and disc diameters are available to accommodate varying degrees and etiologies of heart failure.
Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
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활성 비교기: no Device group (Control Group)
Patients will receive maximally tolerated guideline-directed medical therapy for heart failure only
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Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months
기간: From enrollment to the end of treatment at 12 months
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A composite event of all-cause mortality, heart transplantation or left ventricular assist device implantation due to heart failure, heart failure-related rehospitalization post-procedure and Unplanned outpatient worsening heart failure within 12 months.
Hospitalization for heart failure requires an admission to an in-patient unit or an emergency room stay for ≥24 hours (or <24 hours if subject dies in the emergency room).
- Outpatient worsening heart failure requires an unplanned visit to a doctor's office, urgent care center or emergency room visit with stay <24 hours.
- Worsening heart failure must be present for both conditions, the definition of which requires all three of the following to be present: 1. Deterioration of HF symptoms: at least 1 of the following symptoms 2. Deterioration of HF signs: 2 physical examination findings or 1 physical examination + 1 laboratory or invasive finding 3. Urgent escalation of therapy
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From enrollment to the end of treatment at 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）
기간: From enrollment to the end of treatment at 12 months
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Change in exercise capacity post-procedure: 6-Minute Walk Test
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From enrollment to the end of treatment at 12 months
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New York Heart Association (NYHA) Functional Classification (I-IV, higher scores indicate a worse outcome）
기간: From enrollment to the end of treatment at 12 months
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Change in New York Heart Association (NYHA) Functional Classification
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From enrollment to the end of treatment at 12 months
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Change in NT-proBNP levels
기간: From enrollment to the end of treatment at 12 months
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Change in NT-proBNP levels
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From enrollment to the end of treatment at 12 months
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Left atrial diameter
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic Left atrial diameter
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From enrollment to the end of treatment at 12 months
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Device Success Rates (Treatment Group)
기간: From enrollment to the end of treatment at 12 months
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Device Success is defined as successful implantation of the shunt with normal morphology and position, visible left-to-right shunt on echocardiography, and an immediate decrease in mean Left Atrial Pressure (mLAP) or mean Pulmonary Capillary Wedge Pressure (mPCWP) compared to pre-implantation.
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From enrollment to the end of treatment at 12 months
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Changes in 12-lead Electrocardiogram (ECG)
기간: From enrollment to the end of treatment at 12 months
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Presence of arrhythmias
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From enrollment to the end of treatment at 12 months
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Shunt Orifice Patency/Occlusion Status (Treatment Group)
기간: From enrollment to the end of treatment at 12 months
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Shunt Orifice Patency/Occlusion Status (Treatment Group)
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From enrollment to the end of treatment at 12 months
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All-cause mortality rate
기간: From enrollment to the end of treatment at 12 months
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All-cause mortality rate
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From enrollment to the end of treatment at 12 months
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Number of HF-related rehospitalizations post-procedure
기간: From enrollment to the end of treatment at 12 months
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Number of HF-related rehospitalizations post-procedure
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From enrollment to the end of treatment at 12 months
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Kansas City Cardiomyopathy Questionnaire (KCCQ) score (0-100, higher scores indicate a better outcome）
기간: From enrollment to the end of treatment at 12 months
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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
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From enrollment to the end of treatment at 12 months
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Right atrial diameter
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic right atrial diameter
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From enrollment to the end of treatment at 12 months
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Left ventricular diameter
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic left ventricular diameter
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From enrollment to the end of treatment at 12 months
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Right ventricular diameter
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic reft atrial diameter
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From enrollment to the end of treatment at 12 months
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Left Ventricular Ejection Fraction
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic Left Ventricular Ejection Fraction
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From enrollment to the end of treatment at 12 months
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Tricuspid Annular Plane Systolic Excursion
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic Tricuspid Annular Plane Systolic Excursion
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From enrollment to the end of treatment at 12 months
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Right Ventricular Fractional Area
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic Right Ventricular Fractional Area
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From enrollment to the end of treatment at 12 months
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Aortic regurgitation
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic aortic regurgitation
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From enrollment to the end of treatment at 12 months
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Mitral regurgitation
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic mitral regurgitation
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From enrollment to the end of treatment at 12 months
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Tricuspid regurgitation
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic tricuspid regurgitation
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From enrollment to the end of treatment at 12 months
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Shunt orifice diameter
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic Shunt orifice diameter
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From enrollment to the end of treatment at 12 months
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Shunt flow velocity
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic shunt flow velocity
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From enrollment to the end of treatment at 12 months
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Trans-shunt pressure gradient
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic trans-shunt pressure gradient
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From enrollment to the end of treatment at 12 months
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Shunt flow direction
기간: From enrollment to the end of treatment at 12 months
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Echocardiographic shunt flow direction
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From enrollment to the end of treatment at 12 months
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Procedural Success Rates (Treatment Group)
기간: From enrollment to the end of treatment at 12 months
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Procedural Success is defined as achieving Device Success with the patient surviving to hospital discharge.
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From enrollment to the end of treatment at 12 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Device-Related Adverse Events
기간: From enrollment to the end of treatment at 12 months
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Cardiac tamponade Air embolism Systemic embolization syndrome Thrombus formation on the device surface Device malfunction requiring emergency surgical removal
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From enrollment to the end of treatment at 12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Guangyuan Song, M.D., Beijing Anzhen Hospital
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)
2024년 11월 25일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 7월 16일
QC 기준을 충족하는 최초 제출
2026년 9월 9일
처음 게시됨 (실제)
2026년 9월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 9일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- BeijingAnzhen20260716
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .