Clinical trial 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 study wants to see if the FreeFlow shunt is safe and if it can lower death and hospital readmissions in these patients.
- Who it's for
- Adults with idiopathic pulmonary arterial hypertension who meet the study’s inclusion and exclusion rules.
- What's involved
- Participants will have a balloon opening of the heart’s septum and then receive the FreeFlow shunt. They will be checked 24 hours after the procedure, then at 1, 3, 6 and 12 months.
- Time commitment
- The study lasts one year, with visits at 24 hours, 1, 3, 6 and 12 months after the shunt is placed.
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.
- 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 is enrolling
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.