FreeFlow Percutaneous Atrial Septal Shunt for IPAH

Shanghai Zhongshan Hospital30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

All-cause mortality at 6 months

Time frame: 6 months

Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension

Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension within 6 months

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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.

Time frame: 12 months

The WHO functional class was changed 12 months after operation

Time frame: 12 months

Changes in NT-pro BNP at 12 months after surgery

Time frame: 12 months

The change of exercise capacity (6min walking test) was observed 12 months after operation

Time frame: 12 months

The change of subjects' Kansas City Cardiomyopathy Quality of Life Questionnaire score at 12 months after surgery

Time frame: 12 months

Cumulative number of readmissions associated with exacerbation of pulmonary hypertension at 12 months after surgery

Time frame: 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.

Time frame: 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.

Time frame: through study completion, an average of 1 year

FreeFlow Percutaneous Atrial Septal Shunt for IPAH

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts