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FreeFlow Percutaneous Atrial Septal Shunt for IPAH

NCT06605794 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-09-20

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

FreeFlow percutaneous atrial septal shunt

The trial devices included a percutaneous atrial septal shunt and an atrial septal shunt delivery system. The specifications of the atrial septal shunt device were -φ5, φ7, φ9, φ11, and the specifications of the atrial septal shunt delivery system-FFISS-B were 9F and 10F.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Junbo GE, Prof. · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-11
Primary Completion
2027-09-11
Completion
2027-09-11

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06605794 on ClinicalTrials.gov