Atrial Shunt for the Treatment of Heart Failure With Reduced Ejection Fraction (PAST-HFrEF)
2026年9月9日 更新者：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)
調査の概要
状態
募集
詳細な説明
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).
研究の種類
介入
入学 (推定)
208
段階
- フェーズ2
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sanshuai Chang, M.D.
- 電話番号：+8618501369869
- メール：18501369869@163.com
研究連絡先のバックアップ
- 名前：Guangyuan Song, M.D.
- 電話番号：+8613801120805
- メール：songgy_anzhen@vip.163.com
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100029
- 募集
- Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital
-
コンタクト：
- Sanshuai Chang, M.D.
- 電話番号：+8618501369869
- メール：18501369869@163.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Device group (Interventional group)
Patients will receive atrial shunt for heart failure treatment plus maximally tolerated guideline-directed medical therapy for cardiovascular disease
|
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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
6-minute walk distance (6MWD) (0-1000m, higher scores indicate a better outcome）
時間枠：From enrollment to the end of treatment at 12 months
|
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）
時間枠：From enrollment to the end of treatment at 12 months
|
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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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）
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：From enrollment to the end of treatment at 12 months
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Echocardiographic aortic regurgitation
|
From enrollment to the end of treatment at 12 months
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Mitral regurgitation
時間枠：From enrollment to the end of treatment at 12 months
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Echocardiographic mitral regurgitation
|
From enrollment to the end of treatment at 12 months
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Tricuspid regurgitation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：From enrollment to the end of treatment at 12 months
|
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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Device-Related Adverse Events
時間枠：From enrollment to the end of treatment at 12 months
|
Cardiac tamponade Air embolism Systemic embolization syndrome Thrombus formation on the device surface Device malfunction requiring emergency surgical removal
|
From enrollment to the end of treatment at 12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Guangyuan Song, M.D.、Beijing Anzhen Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年11月25日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年7月16日
QC基準を満たした最初の提出物
2026年9月9日
最初の投稿 (実際)
2026年9月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月9日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- BeijingAnzhen20260716
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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