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New treatment option for Pulmonary Arterial Hypertension
Official title FreeFlow Percutaneous Atrial Septal Shunt for IPAH
ClinicalTrials.gov ID: NCT06605794
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 18≤ age ≤70 years old, female or male;
- 10 mmHg≤ mean right atrial pressure (mRAP) ≤20 mmHg;
- The people had severe idiopathic pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmHg);
- WHO grade III or IV;
- NT-proBNP≥650 ng/L;
You likely can't join if
- 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;
See the full eligibility criteria
- 18≤ age ≤70 years old, female or male;
- 10 mmHg≤ mean right atrial pressure (mRAP) ≤20 mmHg;
- The people had severe idiopathic pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmHg);
- WHO grade III or IV;
- NT-proBNP≥650 ng/L;
- The people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.