FreeFlow Percutaneous Atrial Septal Shunt for IPAH

NCT ID: NCT06605794

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2027-09-11

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.

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device-intervention Group

FreeFlow percutaneous atrial septal shunt

Group Type: EXPERIMENTAL

FreeFlow percutaneous atrial septal shunt

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junbo GE, Prof.

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

180 Fenglin Road

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Daxin ZHOU, Prof.

Role: CONTACT

zhou.daxin@zs-hospital.sh.cn

13801641252

Dandan CHEN, Prof.

Role: CONTACT

chen.dandan@zs-hospital.sh.cn

13788926105

Facility Contacts

Dandan CHEN, Dr

Role: primary

chen.dandan@zs-hospital.sh.cn

+8613788926105

Daxin ZHOU, Dr

Role: backup

zhou.daxin@zs-hospital.sh.cn

+8613801641252

Other Identifiers

2023-111R

Identifier Type: -

Identifier Source: org_study_id