NCT07726927

Brief Summary

A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the efficacy and safety of the patent foramen ovale suture system in the closure treatment of patent foramen ovale. A parallel controlled comparison will be conducted using the Amplatzer PFO Occluder manufactured by Abbott Medical Devices (Shanghai) co., Ltd. as the control device, to evaluate the safety and efficacy of the Patent Foramen Ovale Suture System in the closure treatment of patent foramen ovale.

Trial Health

65
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Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
71mo left

Started Jun 2026

Longer than P75 for not_applicable

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 Progress4%
Jun 2026Jul 2032

Study Start

First participant enrolled

June 30, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2032

Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 21, 2026

Last Update Submit

July 21, 2026

Conditions

Patent Foramen Ovale (PFO)

Outcome Measures

Primary Outcomes (1)

  • Successful occlusion rate at 360 days postoperatively

    360 days postoperatively

Study Arms (2)

PFO Suture System

EXPERIMENTAL
Device: Patent Foramen Ovale Suture System

Amplatzer PFO Occluder

OTHER
Device: Amplatzer PFO Occluder

Interventions

Patent Foramen Ovale Suture SystemDEVICE

In the experimental group, patients with patent foramen ovale (PFO) received PFO closure therapy using the Patent Foramen Ovale Suture System developed by Shenzhen Bihe Medical Co., Ltd.

PFO Suture System
Amplatzer PFO OccluderDEVICE

In the control group, patients with patent foramen ovale (PFO) received PFO closure therapy using the Amplatzer PFO Occluder developed by Abbott Medical Devices(Shanghai) Co., Ltd.

Amplatzer PFO Occluder

Eligibility Criteria

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

You may qualify if:

  • The subject is aged between 18 and 65 years old;
  • Patent foramen ovale (PFO) confirmed by imaging examination with moderate or greater right-to-left shunt (RLS) (both condition a and b shall be satisfied simultaneously):a) Patent foramen ovale (PFO) confirmed by echocardiography (TTE or TEE);b) Moderate or greater right-to-left shunt confirmed by contrast echocardiography (cTTE, cTEE or cTCD);
  • The subject or legal guardian understands the trial purpose, voluntarily participates in the trial, signs the written informed consent form, and is willing to complete follow-up in accordance with the protocol requirements.

You may not qualify if:

  • Carotid atherosclerotic stenosis (stenosis degree \>50% confirmed by ultrasound or CTA);
  • Large cerebral infarction within 4 weeks (defined by imaging as hypodense area on CT involving more than 1/2 of the MCA perfusion territory, or infarct volume\>145 ml on diffusion-weighted imaging (DWI));
  • Intracardiac thrombus or tumor, intracardiac vegetation;
  • Acute myocardial infarction or unstable angina within 6 months;
  • Presence of left ventricular aneurysm or left ventricular wall motion abnormality;
  • Severe valvular heart disease, such as severe mitral regurgitation or stenosis, severe aortic regurgitation or stenosis, mitral or aortic valve vegetation;
  • Combined cardiomyopathy (including hypertrophic cardiomyopathy, restrictive cardiomyopathy, dilated cardiomyopathy, etc.);
  • Severe heart failure with LVEF \<35%;
  • Pulmonary hypertension (mPAP \>25 mmHg);
  • Right-to-left shunt caused by other etiologies, including atrial septal defect or pulmonary arteriovenous fistula;
  • Concomitant atrial fibrillation or atrial flutter;
  • Active endocarditis or other untreated infections;
  • Thrombosis in the access vessel or conditions interfering with the normal deployment of the study device;
  • Hepatic and renal dysfunction (alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the upper limit of normal, or serum creatinine (Cr) \>2 times the upper limit of normal);
  • Coagulopathy or contraindications to antiplatelet or anticoagulant therapy;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Quan Bingrui

CONTACT

+8613263266196quanbingrui@lifetechmed.com

Study Design

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

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 27, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

July 31, 2032

Last Updated

July 27, 2026

Record last verified: 2026-07