Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders

March 10, 2023 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accurate success rate
Time Frame: 6 month
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Success rate of occluder implantation technology
Time Frame: one week after surgery
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
Time Frame: one week after surgery
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
Time Frame: 180 days after surgery
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
Time Frame: 360 days after surgery
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
Time Frame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery
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
Time Frame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery
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
Time Frame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery
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)
Time Frame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery
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.
Time Frame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lifetech Scientific (Shenzhen) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiangbin Pan, Doctor, Fuwai Yunnan Cardiovascular Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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