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Study on the Safety and Effectiveness of the SnowyTM PFO Closure System

Primary Purpose

Patent Foramen Ovale

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

SnowyTM PFO closure system

Cardi-o-fix PFO occluder

About this trial

This is an interventional prevention trial for Patent Foramen Ovale

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 18 to 65 years old, regardless of gender
Transthoracic echocardiographic contrast echocardiography (cTTE) confirmed the presence of PFO and at least moderate (see above definition) RLS (in Valsalva active/resting state)
Existence of at least one of the following conditions： 1) Unexplained stroke or TIA 2) intractable or chronic migraine
The subjects are informed of the nature of the study and agreed to all requirements for participation in the study, signed the informed consent form, and agree to complete the follow-up and follow-up examination

Exclusion Criteria:

Patients have definite causes of stroke unrelated to the PFO
RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt
Atrial fibrillation or atrial flutter
Mitral and aortic stenosis or severe regurgitation
Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy
Active endocarditis or other untreated infectious diseases
Left ventricular ejection fraction (LVEF) < 40%, or NYHA cardiac function grade III-IV
Uncontrollable hypertension
Previous intracardiac surgery
Myocardial infarction or unstable angina pectoris within 6 months
Contraindications to anticoagulants or antiplatelet drugs
High risk of bleeding
severe liver function impairment（alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value）
Serum creatinine greater than 2 times the upper limit of normal or with any history of renal dialysis or renal transplantation
Severe pulmonary disease including pulmonary hypertension (clinical diagnosis)
Nickel or contrast allergy
Active or planned (within 12 months) pregnancy, or lactating female patients
Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months
Psychiatric conditions that may interfere with medical compliance and compliance with follow-up
Concomitant participation in other clinical trials
The investigator determines that the patient is unsuitable because of reasons not listed but thought to interfere with safe trial participation

Sites / Locations

The First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

treatment group

control group

Arm Description

Percutaneously occlusion of PFO with SnowyTM PFO closure system

Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder

Outcomes

Primary Outcome Measures

The success rate of PFO effective occlusion

The amount of right to left shunt (RLS) confirmed by imaging examination after occluder implantation is grade 0-I

Secondary Outcome Measures

Number of Participants with Device success

The successful implantation of occluder is defined as the successful delivery and release of occluder during operation, the position of occluder is appropriate and the morphological structure is normal

Number of Participants with Procedural success

The occluder is successfully implanted and there are no severe adverse events (SAE) during routine hospitalization. SAE include but are not limited to death, systemic embolism, occluder embolism/displacement, occluder thrombosis, heart injury and perforation, pericardial tamponade / pericardial effusion (pericardial effusion leads to hemodynamic damage or requires pericardiocentesis; prolonged hospitalization for more than 48 hours; hospitalization is required), infective endocarditis, atrial fibrillation, severe vascular access complications

Complete closure rate

No RLS is confirmed by imaging examination after occluder implantation

Migraine Headache Impact Test (HIT-6) scores 6 months after operation (compared with baseline)

The scores range from 36 to 78 (higher scores mean a worse outcome).

Incidence of serious adverse events

Events that cause death or serious deterioration of health conditions during clinical trials, including fatal diseases or injuries, permanent defects in body structure or function, and the need for medical or surgical intervention to avoid permanent defects in body structure or function

Incidence of device-related adverse events

Adverse medical events related to the use of devices during clinical trials

All-cause mortality during follow-up

All-cause stroke during follow-up

Full Information

NCT ID

NCT05360771

First Posted

April 23, 2022

Last Updated

June 5, 2023

Sponsor

Hangzhou Dinova EP Technology Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05360771

Brief Title

Study on the Safety and Effectiveness of the SnowyTM PFO Closure System

Official Title

A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Effectiveness of the SnowyTM PFO Closure System in Plugging Patent Foramen Ovale

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 20, 2023 (Anticipated)

Primary Completion Date

December 20, 2023 (Anticipated)

Study Completion Date

December 20, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hangzhou Dinova EP Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale

Detailed Description

A prospective, multicenter, randomized controlled clinical trial is conducted to evaluate the safety and effectiveness of PFO closure system produced by Hangzhou Dinova EP Technology Co., Ltd.., Ltd. in closing patent foramen ovale (PFO). 242 patients are expected to be selected. They are randomly divided into the PFO closure system treatment group (121 cases) and the Chinese medicine Shengjie Cardi-o-fix PFO occluder treatment group (121 cases) according to 1:1. All patients will be followed up to 7 days after operation or before discharge, 1 month, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patent Foramen Ovale

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Arm Description

Percutaneously occlusion of PFO with SnowyTM PFO closure system

Arm Title

control group

Arm Type

Experimental

Arm Description

Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder

Intervention Type

Device

Intervention Name(s)

SnowyTM PFO closure system

Intervention Description

Percutaneously occlusion of PFO with SnowyTM PFO closure system

Intervention Type

Device

Intervention Name(s)

Cardi-o-fix PFO occluder

Intervention Description

Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder

Primary Outcome Measure Information:

Title

The success rate of PFO effective occlusion

Description

The amount of right to left shunt (RLS) confirmed by imaging examination after occluder implantation is grade 0-I

Time Frame

6 months after the procedure

Secondary Outcome Measure Information:

Title

Number of Participants with Device success

Description

Time Frame

immediately after the procedure

Title

Number of Participants with Procedural success

Description

Time Frame

immediately after the procedure

Title

Complete closure rate

Description

No RLS is confirmed by imaging examination after occluder implantation

Time Frame

6 months after the procedure

Title

Migraine Headache Impact Test (HIT-6) scores 6 months after operation (compared with baseline)

Description

The scores range from 36 to 78 (higher scores mean a worse outcome).

Time Frame

6 months after the procedure

Title

Incidence of serious adverse events

Description

Time Frame

5 years after the procedure

Title

Incidence of device-related adverse events

Description

Adverse medical events related to the use of devices during clinical trials

Time Frame

5 years after the procedure

Title

All-cause mortality during follow-up

Time Frame

5 years after the procedure

Title

All-cause stroke during follow-up

Time Frame

5 years after the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 18 to 65 years old, regardless of gender Transthoracic echocardiographic contrast echocardiography (cTTE) confirmed the presence of PFO and at least moderate (see above definition) RLS (in Valsalva active/resting state) Existence of at least one of the following conditions： 1) Unexplained stroke or TIA 2) intractable or chronic migraine The subjects are informed of the nature of the study and agreed to all requirements for participation in the study, signed the informed consent form, and agree to complete the follow-up and follow-up examination Exclusion Criteria: Patients have definite causes of stroke unrelated to the PFO RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt Atrial fibrillation or atrial flutter Mitral and aortic stenosis or severe regurgitation Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy Active endocarditis or other untreated infectious diseases Left ventricular ejection fraction (LVEF) < 40%, or NYHA cardiac function grade III-IV Uncontrollable hypertension Previous intracardiac surgery Myocardial infarction or unstable angina pectoris within 6 months Contraindications to anticoagulants or antiplatelet drugs High risk of bleeding severe liver function impairment（alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value） Serum creatinine greater than 2 times the upper limit of normal or with any history of renal dialysis or renal transplantation Severe pulmonary disease including pulmonary hypertension (clinical diagnosis) Nickel or contrast allergy Active or planned (within 12 months) pregnancy, or lactating female patients Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months Psychiatric conditions that may interfere with medical compliance and compliance with follow-up Concomitant participation in other clinical trials The investigator determines that the patient is unsuitable because of reasons not listed but thought to interfere with safe trial participation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kong Xiangqing, MD

Phone

+8602563806360

xiangqing_kong@sina.com

Facility Information:

Facility Name

The First Affiliated Hospital of Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kong Xiangqing, MD

First Name & Middle Initial & Last Name & Degree

Peng Xiaoping, MD

First Name & Middle Initial & Last Name & Degree

Cheng Ziying, MD

12. IPD Sharing Statement

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Study on the Safety and Effectiveness of the SnowyTM PFO Closure System

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