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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
180 Fenglin Road
RECRUITING
Shanghai
Contact Information
Primary
Daxin ZHOU, Prof.
zhou.daxin@zs-hospital.sh.cn
13801641252
Backup
Dandan CHEN, Prof.
chen.dandan@zs-hospital.sh.cn
13788926105
Time Frame
Start Date: 2023-09-11
Estimated Completion Date: 2027-09-11
Participants
Target number of participants: 30
Treatments
Experimental: Device-intervention Group
FreeFlow percutaneous atrial septal shunt
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov