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Status:

RECRUITING

FreeFlow Percutaneous Atrial Septal Shunt for IPAH

Lead Sponsor:

Shanghai Zhongshan Hospital

Conditions:

Pulmonary Arterial Hypertension

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

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 i...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 11 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 11 2027

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06605794

Start Date

September 11 2023

End Date

September 11 2027

Last Update

September 20 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

180 Fenglin Road

Shanghai, Shanghai Municipality, China, 200032