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Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension

RecruitingNAAges 6 Months - 18 YearsAllChina National Center for Cardiovascular Diseases
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In plain words

What the trial is, and whether it could suit you

This is a multi-center, perspective, and exploratory study aimed at evaluating the 3-years clinical outcome of Potts-shunt procedure for pediatric patients with severe pulmonary artery hypertension (PAH). The included criteria are as followed: 1)6 months \< age โ‰ค 18 years; 2) ESC 2022 Group I PAH; 3) Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to high/high-risk status of the criteria of ESC2022; 4) Presenting with significant clinical manifestations (i.e., progressive symptoms/syncope history/growth and development restriction, etc); 5) Informed consent form signed by the patient and their guardian. The excluded criteria are as followed: 1) ESC 2022 Group II-V PAH; 2) Poor right ventricular function: RVEF \< 25% or RVFAC \< 20%; 3) Deteriorated general condition: requiring ICU resuscitation or ECMO assistance; 4) Pulmonary artery press

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 6 months \&lt; age โ‰ค 18 years; 2. ESC 2022 Group I PAH; 3. Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to high/high-risk status of the criteria of ESC2022; 4. Presenting with significant clinical manifestations (i.e., progressive symptoms/syncope history/growth and development restriction, etc); 5. Informed consent form signed by the patient and their guardian. Exclusion Criteria: 1. ESC 2022 Group II-V PAH; 2. Poor right ventricular function: RVEF \&lt; 25% or RVFAC \&lt; 20%; 3. Deteriorated general condition: requiring ICU resuscitation or ECMO assistance; 4. Pulmonary artery pressure/main arterial pressure ratio \&lt; 0.7; 5. Six-minute walk distance \&lt; 150 meters (only applicable to patients aged 8 and above); 6. No significant improvement in RVEF under triple drug therapy.
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What it tests

  • Comprehensive therapy combined Potts-shunt procedure and conventional drug therapy
  • Only conventional drug therapy
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Where

1 site
Pediatric cardic surgical center, Fuwai Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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