FreeFlow Percutaneous Atrial Septal Shunt for IPAH
Recruiting
N/A
Interventional Study
Pulmonary Arterial Hypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Shanghai Zhongshan Hospital · Other
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About This Trial
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 …
Trial Locations
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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…
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