MedTrace Logo

Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System

NCT07300358 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2025-12-23

No results posted yet for this study

Summary

To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)

Conditions

  • Cardiovascular Diseases
  • Cardiovascular Abnormality
  • Heart Defects, Congenital
  • Heart Septal Defects
  • Heart Septal Defects, Atrial
  • Foramen Ovale, Patent
  • Stroke, Ischemic
  • Stroke (CVA) or TIA

Interventions

DEVICE

Active Comparator

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

DEVICE

Experimental

Transcatheter closure of a patent foramen ovale (PFO) with biodegradable PFO occluder

Sponsors & Collaborators

  • Shanghai Lingsi Medical Technology Co., Ltd.

    lead OTHER

Principal Investigators

  • XiangBin Pan, Doctor · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2027-06-30
Completion
2027-06-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300358 on ClinicalTrials.gov