Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605794
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
FreeFlow Percutaneous Atrial Septal Shunt for IPAH
Sponsor:
None
Organization:
None
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:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None