Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders

NCT05312554 | Withdrawn

• 1 other identifier: 21CT(CN)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the performance of patent foramen ovale (PFO) device developed by Lifetech Technology (Shenzhen) Co., LTD

Conditions

Patent Foramen Ovale; Cryptogenic Stroke

Outcome Measures

Primary Outcomes (1)

• Accurate success rate

  180 days after the operation, transthoracic echocardiography (TTE) showed that the position and shape of the occluders were normal, and no horizontal atrial shunt was observed. Re-examination by chest echocardiographic contrast echocardiography (cTTE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after resting state and Valsalva action.

  6 month

Secondary Outcomes (9)

• Success rate of occluder implantation technology

  one week after surgery

• Success rate of occluder implantation

  one week after surgery

• Success rate of complete occlusion

  180 days after surgery

• Effective plugging success rate

  360 days after surgery

• Recurrence or incidence of cryptogenic stroke during follow-up

  360 days, 2 years, 3 years, 4 years, 5 years after surgery

Study Arms (1)

Intervention arm

EXPERIMENTAL

Patients with cryptogenic stroke complicated with patent foramen ovale,and passed the screening and signed the informed consent form

Device: Iris FIT™ PFO closure system

Interventions

Iris FIT™ PFO closure system DEVICE

Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with the Iris Patent foramen ovale occluder according to the INSTRUCTIONS for Use (IFU)

Intervention arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18-60 years;
• Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent;
• Patent foramen ovale was confirmed by chest ultrasound (TTE) or esophageal ultrasound (TEE);
• The presence of a large right-to-left shunt was confirmed by right aspiration angiography (cTTE or cTCD);
• It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists:
• Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors;
• Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale;
• Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;
• Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy.

You may not qualify if:

• Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (\> 50%);
• Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score \<6 points or infarction volume ≥70 ml or infarction area \> 1/3 middle cerebral artery blood supply area);
• intracardiac thrombosis or tumor, intracardiac neoplasm;
• acute myocardial infarction or unstable angina within 6 months;
• Left ventricular aneurysm formation or left ventricular wall movement disorder;
• Mitral/aortic disease: including mitral stenosis or severe mitral regurgitation of any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve vegetations or prior valve replacement surgery;
• Dilated cardiomyopathy, LVEF \< 35%, or other severe heart failure;
• Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;
• Atrial fibrillation/atrial flutter (chronic or intermittent);
• pregnant or planning to become pregnant during the trial;
• Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;
• Pulmonary hypertension or patent foramen ovale was a special channel;
• liver and kidney function impairment (ALT or AST \> 3 times the upper limit of normal value, serum creatinine (Cr) \> 2 times the upper limit of normal value);
• Uncontrolled hypertension (\> 180/100 mmHg);
• Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (1)

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Foramen Ovale, Patent; Ischemic Stroke

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Xiangbin Pan, Doctor

  Fuwai Yunnan Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 5, 2022
• Study Start: April 12, 2022
• Primary Completion: December 25, 2023
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)