Potts-shunt procedure for children with severe pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, prospective study evaluates the clinical outcomes of the Potts-shunt procedure in pediatric patients aged 6 months to 18 years suffering from severe pulmonary artery hypertension (PAH). Participants must have undergone standardized drug therapy for at least 6-9 months and still exhibit significant clinical symptoms. The study aims to assess the effectiveness of combining the Potts-shunt procedure with conventional drug therapy compared to drug therapy alone over a three-year period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 6 months \< age ≤ 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 \< 25% or RVFAC \< 20%;
3. Deteriorated general condition: requiring ICU resuscitation or ECMO assistance;
4. Pulmonary artery pressure/main arterial pressure ratio \< 0.7;
5. Six-minute walk distance \< 150 meters (only applicable to patients aged 8 and above);
6. No significant improvement in RVEF under triple drug therapy.

Where it's running

• Pediatric cardic surgical center, Fuwai Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Shoujun Li, MD
• Email: drlishoujunfw@163.com
• Phone: +8613501071589

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.