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Patent Foramen OvaleNCT05360771

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

A study testing SnowyTM PFO closure system and Cardi-o-fix PFO occluder in people with Patent Foramen Ovale, run by Hangzhou Dinova EP Technology Co., Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Patent Foramen Ovale
What is being tested?
SnowyTM PFO closure system and Cardi-o-fix PFO occluder
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
1 siteChina
Study dates
20 Oct 2023to 20 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kong Xiangqing, MD contact

+8602563806360

xiangqing_kong@sina.com

China1 site

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Kong Xiangqing, MD

    Peng Xiaoping, MD

Other trials in China

About this study

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

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

Read the 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.

Being tested
SnowyTM PFO closure system, Cardi-o-fix PFO occluder
Medical subject headings
Foramen Ovale, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SnowyTM PFO closure systemDevice

    Percutaneously occlusion of PFO with SnowyTM PFO closure system

  • Cardi-o-fix PFO occluderDevice

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

Study groups in NCT05360771
Study groupRoleWhat they receive
treatment groupExperimentalPercutaneously occlusion of PFO with SnowyTM PFO closure system
Receives: Device: SnowyTM PFO closure system
control groupExperimentalPercutaneously occlusion of PFO with Cardi-o-fix PFO occluder
Receives: Device: Cardi-o-fix PFO occluder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months after the procedure

Secondary outcomes (8)

  1. 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

    Measured: immediately after the procedure

  2. 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

    Measured: immediately after the procedure

  3. Complete closure rate

    No RLS is confirmed by imaging examination after occluder implantation

    Measured: 6 months after the procedure

  4. 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).

    Measured: 6 months after the procedure

  5. 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

    Measured: 5 years after the procedure

  6. Incidence of device-related adverse events

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

    Measured: 5 years after the procedure

  7. All-cause mortality during follow-up

    Measured: 5 years after the procedure

  8. All-cause stroke during follow-up

    Measured: 5 years after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2022
  2. Study start20 Oct 2023 (estimated)
  3. Primary completion20 Dec 2023 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
242 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05360771
Sponsor's protocol ID
PFO-001
Status last verified
Jun 2023
First submitted
23 Apr 2022
Last updated
7 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing SnowyTM PFO closure system and Cardi-o-fix PFO occluder in people with Patent Foramen Ovale, run by Hangzhou Dinova EP Technology Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kong Xiangqing, MD (+8602563806360, xiangqing_kong@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The success rate of PFO effective occlusion (time frame: 6 months after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05360771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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