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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device-intervention Group | Experimental | FreeFlow percutaneous atrial septal shunt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeFlow percutaneous atrial septal shunt | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daxin ZHOU, Prof. | Contact | 13801641252 | zhou.daxin@zs-hospital.sh.cn | |
| Dandan CHEN, Prof. | Contact | 13788926105 | chen.dandan@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junbo GE, Prof. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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 |