Using a new device to treat severe pulmonary arterial hypertension

A Prospective, Multi-center Study to Evaluate the Safety and Efficacy of FreeFlow Percutaneous Atrial Septal Shunt in Patients With Idiopathic Pulmonary Arterial Hypertension

This study is testing a new device to see if it can help people with severe pulmonary arterial hypertension live longer and avoid hospital visits.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06605794 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of the FreeFlow percutaneous atrial septal shunt in patients suffering from idiopathic pulmonary arterial hypertension. Participants will undergo a balloon atrial septostomy followed by the implantation of the shunt, with follow-up assessments scheduled at various intervals up to one year. The study aims to determine if this intervention can reduce mortality and hospital readmissions associated with the condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with severe idiopathic pulmonary hypertension and specific clinical criteria.

Not a fit: Patients with severe coagulopathy, acute infections, or significant liver dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with severe pulmonary arterial hypertension.

How similar studies have performed: While similar approaches have been explored, the specific use of the FreeFlow device in this context is relatively novel.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• 180 Fenglin Road — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Junbo GE, Prof. — Fudan University
• Study coordinator: Daxin ZHOU, Prof.

Conditions Pulmonary Arterial Hypertension