Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-31 @ 7:34 PM
Study NCT ID:
NCT06605794
Status:
RECRUITING
Last Update Posted:
2024-09-20
First Post:
2024-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FreeFlow Percutaneous Atrial Septal Shunt for IPAH
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Study Overview
Official Title:
A Prospective, Multi-center Study to Evaluate the Safety and Efficacy of FreeFlow Percutaneous Atrial Septal Shunt in Patients With Idiopathic Pulmonary Arterial Hypertension
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FREEFLOW
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 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: