NCT05360771

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Oct 2023Dec 2027

First Submitted

Initial submission to the registry

April 23, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2027

Expected
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

April 23, 2022

Last Update Submit

June 5, 2023

Conditions

Patent Foramen Ovale

Outcome Measures

Primary Outcomes (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

    6 months after the procedure

Secondary Outcomes (8)

  • Number of Participants with Device success

    immediately after the procedure

  • Number of Participants with Procedural success

    immediately after the procedure

  • Complete closure rate

    6 months after the procedure

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

    6 months after the procedure

  • Incidence of serious adverse events

    5 years after the procedure

  • +3 more secondary outcomes

Study Arms (2)

treatment group

EXPERIMENTAL

Percutaneously occlusion of PFO with SnowyTM PFO closure system

Device: SnowyTM PFO closure system

control group

EXPERIMENTAL

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

Device: Cardi-o-fix PFO occluder

Interventions

SnowyTM PFO closure systemDEVICE

Percutaneously occlusion of PFO with SnowyTM PFO closure system

treatment group
Cardi-o-fix PFO occluderDEVICE

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

control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Kong Xiangqing, MD

CONTACT

+8602563806360xiangqing_kong@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2022

First Posted

May 4, 2022

Study Start

October 20, 2023

Primary Completion

December 20, 2023

Study Completion (Estimated)

December 20, 2027

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations

CN(1)