Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders

A Prospective, Multi-Center, Single-Group Goal Value Clinical Trial to Revaluate the Safety and Efficacy of Patent Foramen Ovale Occluders

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

Study Overview

• Status: Withdrawn
• Conditions: Patent Foramen Ovale; Cryptogenic Stroke
• Intervention / Treatment: Device: Iris FIT™ PFO closure system

Detailed Description

The purpose of this prospective, multi-center, single-group target value premarket clinical trial was to evaluate the safety and efficacy of a patent foramen ovale (PFO) occlator developed by Lifetech Technology (Shenzhen) Co., LTD for the treatment of cryptogenic stroke complicated with patent foramen ovale. The study required the implant to follow instructions strictly.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China
      • Fuwai Yunnan Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients aged 18-60 years;
2. Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent;
3. Patent foramen ovale was confirmed by chest ultrasound (TTE) or esophageal ultrasound (TEE);
4. The presence of a large right-to-left shunt was confirmed by right aspiration angiography (cTTE or cTCD);

5. It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists:

   1. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors;
   2. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale;
   3. Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;
   4. Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy.

Exclusion Criteria:

1. Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (> 50%);
2. 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);
3. intracardiac thrombosis or tumor, intracardiac neoplasm;
4. acute myocardial infarction or unstable angina within 6 months;
5. Left ventricular aneurysm formation or left ventricular wall movement disorder;
6. 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;
7. Dilated cardiomyopathy, LVEF < 35%, or other severe heart failure;
8. Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;
9. Atrial fibrillation/atrial flutter (chronic or intermittent);
10. pregnant or planning to become pregnant during the trial;
11. Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;
12. Pulmonary hypertension or patent foramen ovale was a special channel;
13. 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);
14. Uncontrolled hypertension (> 180/100 mmHg);
15. Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;
16. Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;
17. The investigator determined that the patient was not suitable for implantation of PFO occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and the size of the foramen ovale ≥5mm) or the patient has contraindications for implantation of PFO occluder;
18. Thrombosis exists at the location or route of implantation;
19. Malignant neoplasms or other diseases with a life expectancy of less than 2 years;
20. Patients who could not be followed up during the trial;
21. Participate in clinical trials of other drugs or medical devices within three months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of occluder implantation technology	The success of occluder implantation technology is defined as successful intraoperative implantation of occluder and immediate postoperative hypersurgery It was confirmed that the shape and position of the sealing device were appropriate, no new pericardial effusion or valve regurgitation was found, and the perioperative patients survived.	one week after surgery
Success rate of occluder implantation	Successful occluder implantation was defined as successful implantation of occluder and routine postoperative hospitalization There were no serious adverse events related to surgery	one week after surgery
Success rate of complete occlusion	Complete occlusion was defined as the transthoracic echocardiography (TTE) showing occlusion 180 days after surgery The position and shape of the apparatus were normal, and no horizontal atrial shunt was observed. The results of chest echocardiographic contrast echoography (cTTE) were reviewed There was no right-to-left shunt, that is, no microbubbles in the left heart cavity after Valsalva and resting state.	180 days after surgery
Effective plugging success rate	Effective occlusion was defined as: transthoracic echocardiography (TTE) showed the position and shape of the occluder 360 days after the operation Normal condition, no horizontal atrial shunt; Reexamination by chest echocardiographic contrast echocardiography (cTTE) showed no or few results In other words, there were no microbubbles or less than 10 microbubbles in the left heart cavity after Valsalva and resting state	360 days after surgery
Recurrence or incidence of cryptogenic stroke during follow-up	Cryptogenic stroke was defined as a new focal cerebral ischemia confirmed by neuroimaging (cranial MRI or CT), which was performed After extensive vascular, cardiac, and blood evaluation, non-atherosclerotic, cardiogenic, or arteriolar obliterators were identified Cerebral infarction caused by the diagnosis of exclusion.	360 days, 2 years, 3 years, 4 years, 5 years after surgery
All-cause mortality rate	All-cause death is defined as death from any cause during the follow-up period.	360 days, 2 years, 3 years, 4 years, 5 years after surgery
Incidence of new atrial fibrillation and atrial flutter during follow-up period	A prospective, multi-center, single-group goal value clinical trial to evaluate the safety and efficacy of patent foramen ovale occluders	360 days, 2 years, 3 years, 4 years, 5 years after surgery
Incidence of device-related serious adverse events during follow-up (including device-related thrombosis, embolic stroke, and peripheral stroke)	Arterial embolism, III degree ATrioventricular block, heart abrasion, infective endocarditis, severe hemolytic anemia, etc.);	360 days, 2 years, 3 years, 4 years, 5 years after surgery
Incidence of device defects.	Device defects refer to unreasonable risks that may endanger human health and safety under normal use of medical devices in clinical trials, such as label errors, quality problems and failures	360 days, 2 years, 3 years, 4 years, 5 years after surgery

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: Xiangbin Pan, Doctor, Fuwai Yunnan Cardiovascular Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2022
• Primary Completion (Anticipated): December 25, 2023
• Study Completion (Anticipated): March 31, 2028

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Stroke; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Ischemic Stroke; Foramen Ovale, Patent
• Other Study ID Numbers: 21CT(CN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No