NCT06605794 FreeFlow Percutaneous Atrial Septal Shunt for IPAH
| NCT ID | NCT06605794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-09-11 |
| Primary Completion | 2027-09-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-09-11 with a primary completion date of 2027-09-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to explore the safety and efficacy of the FreeFlow percutaneous atrial septal shunt for treatment of idiopathic pulmonary arterial hypertension. The main questions it aims to answer are: * Is the FreeFlow percutaneous atrial septal shunt safe to use in patients with idiopathic pulmonary arterial hypertension? * Does the FreeFlow percutaneous atrial septal shunt reduce all-cause mortality and readmission in patients with idiopathic pulmonary arterial hypertension, and how effective is it? Thirty subjects who met the inclusion and exclusion criteria were selected for selective implantation of FreeFlow percutaneous atrial septal shunts after balloon atrial septostomy. Participants will: * underwent balloon atrial septostomy and FreeFlow percutaneous atrial septal shunt implantation. * will be followed up at 24 hours after shunt implantation or before discharge, 1 month, 3 months, 6 months and 12 months.
Eligibility Criteria
Inclusion Criteria: * 18≤ age ≤70 years old, female or male; * 10 mmHg≤ mean right atrial pressure (mRAP) ≤20 mmHg; * The subjects had severe idiopathic pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmHg); * WHO grade III or IV; * NT-proBNP≥650 ng/L; * The subjects were informed of the nature of the study and agreed to all the requirements for participating in the study. They signed the informed consent form and agreed to complete the follow-up and the examinations required for the follow-up. Exclusion Criteria: * Local or systemic sepsis or other acute infection; * Severe coagulopathy; * Allergy to nickel and/or titanium and/or nickel/titanium-based materials; * Patients with contraindications to antiplatelet, coagulant or thrombotic therapy; * Intolerance to contrast media; * Have participated in other drug or device clinical trials during the same period; * Glomerular filtration rate (GFR) \< 50 mL/min; * Patients with severe liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal); * The patient had malignant arrhythmia; * The patient did not receive standardized drug therapy (triple sequential therapy) according to the Chinese guidelines for the diagnosis and treatment of pulmonary hypertension within 3 months; * Women who are pregnant, planning to become pregnant (within 12 months) or breastfeeding; * Severe restrictive or obstructive lung disease; * Implanted atrial septal defect (ASD)/ patent foramen ovale (PFO) closure device; * Left ventricular ejection fraction (LVEF) \<50%; * SpO2 \< 90% without oxygen inhalation (pulse measurement); * The anatomical structure of the heart is abnormal, and the shunt cannot be implanted on the atrial septum; * Other circumstances in which the patient was deemed by the investigator to be ineligible for inclusion in the trial.
Contact & Investigator
Junbo GE, Prof.
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06605794 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Pulmonary Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06605794 currently recruiting?
Yes, NCT06605794 is actively recruiting participants. Contact the research team at zhou.daxin@zs-hospital.sh.cn for enrollment information.
Where is the NCT06605794 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06605794 clinical trial?
NCT06605794 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Junbo GE, Prof. at Fudan University. The trial plans to enroll 30 participants.