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Patent Foramen OvaleNCT05312554

Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders

A study testing Iris FIT™ PFO closure system in people with Patent Foramen Ovale and Cryptogenic Stroke, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Patent Foramen Ovale, Cryptogenic Stroke
What is being tested?
Iris FIT™ PFO closure system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
12 Apr 2022to 31 Mar 2028
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;
  • 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;
  • Thrombosis exists at the location or route of implantation;
  • Malignant neoplasms or other diseases with a life expectancy of less than 2 years;
  • Patients who could not be followed up during the trial;
  • Participate in clinical trials of other drugs or medical devices within three months.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Yunnan Cardiovascular Hospital

    Kunming, Yunnan

Other trials in China

About this study

Official title: 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

Read the 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.

Being tested
Iris FIT™ PFO closure system
Medical subject headings
Foramen Ovale, Patent, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iris FIT™ PFO closure systemDevice

    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)

Study groups in NCT05312554
Study groupRoleWhat they receive
Intervention armExperimentalPatients with cryptogenic stroke complicated with patent foramen ovale,and passed the screening and signed the informed consent form
Receives: Device: Iris FIT™ PFO closure system

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 month

Secondary outcomes (9)

  1. 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.

    Measured: one week after surgery

  2. 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

    Measured: one week after surgery

  3. 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.

    Measured: 180 days after surgery

  4. 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

    Measured: 360 days after surgery

  5. 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.

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

  6. All-cause mortality rate

    All-cause death is defined as death from any cause during the follow-up period.

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

  7. 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

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

  8. 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.);

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

  9. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start12 Apr 2022
  3. Primary completion25 Dec 2023 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Why it stopped: Company policy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05312554
Sponsor's protocol ID
21CT(CN)
Status last verified
Mar 2023
First submitted
24 Mar 2022
Last updated
14 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Iris FIT™ PFO closure system in people with Patent Foramen Ovale and Cryptogenic Stroke, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accurate success rate (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05312554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.

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