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NCT05360771 | Not yet recruiting | Patent Foramen Ovale

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

Hangzhou Dinova EP Technology Co., Ltd

Brief Summary:

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

Condition or disease

Patent Foramen Ovale

Intervention/treatment

SnowyTM PFO closure system

Cardi-o-fix PFO occluder

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 242 participants
Masking : None (Open Label)
Primary Purpose : Prevention
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
Actual Study Start Date : October 20, 2023
Estimated Primary Completion Date : December 20, 2023
Estimated Study Completion Date : December 20, 2027
Arm Intervention/treatment

Experimental: treatment group

Percutaneously occlusion of PFO with SnowyTM PFO closure system

Device: SnowyTM PFO closure system

Experimental: control group

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

Device: Cardi-o-fix PFO occluder
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Study on the Safety and Effectiveness of the SnowyTM PFO Closure System

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

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Locations

Not yet recruiting

China, Jiangsu

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210029