Actively Recruiting
FreeFlow Percutaneous Atrial Septal Shunt for IPAH
Led by Shanghai Zhongshan Hospital · Updated on 2024-09-20
30
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FreeFlow Percutaneous Atrial Septal Shunt for IPAH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old, female or male
- Mean right atrial pressure between 10 mmHg and 20 mmHg
- Severe idiopathic pulmonary hypertension with mean pulmonary arterial pressure over 45 mmHg
- WHO functional class grade III or IV
- NT-proBNP level greater than or equal to 650 ng/L
- Signed informed consent and agreement to complete all follow-ups and required examinations
You will not qualify if you...
- Local or systemic sepsis or other acute infection
- Severe blood clotting problems
- Allergy to nickel, titanium, or nickel/titanium-based materials
- Contraindications to antiplatelet, coagulant, or thrombotic therapy
- Intolerance to contrast media
- Participation in other drug or device clinical trials during the same period
- Glomerular filtration rate less than 50 mL/min
- Severe liver dysfunction (ALT or AST more than 3 times the upper limit of normal)
- Malignant arrhythmia
- Not receiving standardized triple sequential drug therapy for pulmonary hypertension within the past 3 months
- Women who are pregnant, planning pregnancy within 12 months, or breastfeeding
- Severe restrictive or obstructive lung disease
- Implanted atrial septal defect or patent foramen ovale closure device
- Left ventricular ejection fraction less than 50%
- Blood oxygen saturation below 90% without oxygen
- Abnormal heart anatomy preventing shunt implantation on the atrial septum
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
180 Fenglin Road
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
D
Daxin ZHOU, Prof.
CONTACT
D
Dandan CHEN, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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