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Not yet recruiting NCT05360771

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

No phase Interventional Patent Foramen Ovale

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SnowyTM PFO closure system, Cardi-o-fix PFO occluder.
Who it may be relevant to
Registry conditions: Patent Foramen Ovale. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Device SnowyTM PFO closure system
    Percutaneously occlusion of PFO with SnowyTM PFO closure system
  • Device Cardi-o-fix PFO occluder
    Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder

Primary outcome measures

  • The success rate of PFO effective occlusion [Time frame: 6 months after the procedure]
Secondary outcome measures (8)
  • Number of Participants with Device success [Time frame: immediately after the procedure]
  • Number of Participants with Procedural success [Time frame: immediately after the procedure]
  • Complete closure rate [Time frame: 6 months after the procedure]
  • Migraine Headache Impact Test (HIT-6) scores 6 months after operation (compared with baseline) [Time frame: 6 months after the procedure]
  • Incidence of serious adverse events [Time frame: 5 years after the procedure]
  • Incidence of device-related adverse events [Time frame: 5 years after the procedure]
  • All-cause mortality during follow-up [Time frame: 5 years after the procedure]
  • All-cause stroke during follow-up [Time frame: 5 years after the procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • The First Affiliated Hospital of Nanjing Medical University — Nanjing

Identifiers

NCT: NCT05360771 · PFO-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗