FreeFlow Percutaneous Atrial Septal Shunt for IPAH (FREEFLOW)

A Prospective, Multi-center Study to Evaluate the Safety and Efficacy of FreeFlow Percutaneous Atrial Septal Shunt in Patients With Idiopathic Pulmonary Arterial Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Device: FreeFlow percutaneous atrial septal shunt

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daxin ZHOU, Prof.; Phone Number: 13801641252; Email: zhou.daxin@zs-hospital.sh.cn
• Study Contact Backup: Name: Dandan CHEN, Prof.; Phone Number: 13788926105; Email: chen.dandan@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • 180 Fenglin Road
      • Contact: Dandan CHEN, Dr; Phone Number: +8613788926105; Email: chen.dandan@zs-hospital.sh.cn
      • Contact: Daxin ZHOU, Dr; Phone Number: +8613801641252; Email: zhou.daxin@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device-intervention Group; FreeFlow percutaneous atrial septal shunt	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 6 months	All-cause mortality at 6 months	6 months
Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension	Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension within 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective shunt rate at the end point	Effective shunt was defined as the presence of intra-atrial shunt by echocardiography at 12 months after operation, and the diameter of the shunt was reduced by no more than 2mm compared with the diameter measured by echocardiography before discharge	12 months
Shunt Success rate	Successful shunt operation was defined as successful shunt implantation, normal morphology and position, and basically the expected shunt size under fluoroscopy.	12 months
The WHO functional class was changed 12 months after operation	The WHO functional class was changed 12 months after operation	12 months
Changes in NT-pro BNP at 12 months after surgery	Changes in NT-pro BNP at 12 months after surgery	12 months
The change of exercise capacity (6min walking test) was observed 12 months after operation	The change of exercise capacity (6min walking test) was observed 12 months after operation	12 months
The change of subjects' Kansas City Cardiomyopathy Quality of Life Questionnaire score at 12 months after surgery	The change of subjects' Kansas City Cardiomyopathy Quality of Life Questionnaire score at 12 months after surgery	12 months
Cumulative number of readmissions associated with exacerbation of pulmonary hypertension at 12 months after surgery	Cumulative number of readmissions associated with exacerbation of pulmonary hypertension at 12 months after surgery	12 months
Serious Adverse Event Rate (SAE)	Serious adverse event rate (SAE) refers to events occurring during the course of the clinical trial that lead to death or serious deterioration of health status, including fatal illness or injury, permanent defects in body structure or function, and the need for medical or surgical intervention to avoid permanent defects in body structure or function.	through study completion, an average of 1 year
Device-related Adverse Event Rate (DSAE)	The device-related adverse event rate (DSAE) refers to the adverse medical events related to the use of the device that occurred during the course of the clinical trial.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Junbo GE, Prof., Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): September 11, 2027
• Study Completion (Estimated): September 11, 2027

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: 2023-111R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No