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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHangzhou Dinova EP Technology Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SnowyTM PFO closure system
  • Cardi-o-fix PFO occluder

Treatment groups

242 Participants
are divided into 2 treatment groups