Potts-shunt procedure for children with severe pulmonary hypertension
Multicenter, Prospective, and Exploratory Study of Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension
This study tests if adding the Potts-shunt procedure to standard drug treatment can help children with severe pulmonary hypertension feel better compared to just using the medication alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06429579 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 6 months to 18 years with ESC 2022 Group I PAH who have not responded adequately to drug therapy.
Not a fit: Patients with ESC 2022 Group II-V PAH or those with severely compromised right ventricular function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and clinical outcomes for children with severe pulmonary hypertension.
How similar studies have performed: While the Potts-shunt procedure is a recognized intervention, this specific application in pediatric patients with severe PAH is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Pediatric cardic surgical center, Fuwai Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Shoujun Li, MD
- Email: drlishoujunfw@163.com
- Phone: +8613501071589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.