Using a new device to treat severe pulmonary arterial 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 180 Fenglin Road
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Junbo GE, Prof. — Fudan University
• Study coordinator: Daxin ZHOU, Prof.
• Email: zhou.daxin@zs-hospital.sh.cn
• Phone: 13801641252

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sotatercept in Indian adults with pulmonary arterial hypertension on standard therapy

  This study tests whether adding sotatercept to current PAH medicines is safe and tolerable for adults with PAH in India.

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• Once-daily treprostinil palmitil inhalation powder for PAH

  This study tests whether taking a daily inhaled treprostinil palmitil powder for 24 weeks improves exercise ability in adults with pulmonary arterial hypertension compared to a placebo.

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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.