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New treatment option for Pulmonary Artery Hypertension
Official title Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension
ClinicalTrials.gov ID: NCT06429579
What this study is testing
What is Only conventional drug therapy?
Only conventional drug therapy is an investigational medicine, being studied as a potential treatment for pulmonary artery hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 ≤ 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- 6 months \< age ≤ 18 years;
- ESC 2022 Group I PAH;
- 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;
- Presenting with significant clinical manifestations (i.e., progressive symptoms/syncope history/growth and development restriction, etc);
- Informed consent form signed by the patient and their guardian.
You likely can't join if
- ESC 2022 Group II-V PAH;
- Poor right ventricular function: RVEF \< 25% or RVFAC \< 20%;
- Deteriorated general condition: requiring ICU resuscitation or ECMO assistance;
- Pulmonary artery pressure/main arterial pressure ratio \< 0.7;
- Six-minute walk distance \< 150 meters (only applicable to patients aged 8 and above);
- No significant improvement in RVEF under triple drug therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.