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Atrial FibrillationSAFE-PROTECTNCT04479722

Using Left Atrium Appendage Closure in NVAF Patients With High Risk of Ischemic Stroke

A study testing Left atrial appendage closure procedure in people with Atrial Fibrillation and Stroke, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the safety and efficacy of using Microport CardioAdvance Left Atrium Appendage Closure for preventing stroke in Non-valvular atrial fibrillation (NVAF) patients who have contraindications for long-term anti-coagulation. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Atrial Fibrillation, Stroke
What is being tested?
Left atrial appendage closure procedure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteChina
Study dates
3 Mar 2021to 30 Sep 2026
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non valvular atrial fibrillation subjects aged ≥18 and ≤80;
  • High risk of ischemic stroke: CHA2DS2VASc score ≥ 2 ( ≥ 3 for female) together with any of the following circumstances:
  • With a recorded history (happened earlier than 6 months from now) of bleeding (including gingival/nasal/oral bleeding, skin \&soft tissue bleeding, gastrointestinal bleeding, urinary tract bleeding, cerebral haemorrhage, etc.) or bleeding tendency;
  • Intolerance or rejection of long-term anti-coagulation therapy;
  • Suffering stroke or embolism despite routine anti-coagulation therapy;
  • With a predicting HAS-BLED score ≥3.
  • Subjects (or his/her legal representatives) are able to understand the study objectives, willing to cooperate with procedure and follow-up. Subjects who voluntarily participate in this trial and have signed the written informed consent form.

Who cannot join

  • Subjects with atrial fibrillation (AF) caused by rheumatic valvular disease, moderate to severe mitral stenosis, severe mitral regurgitation, severe aortic valve disease or severe left ventricular outflow tract obstruction with pressure difference greater than 40mmHg;
  • Suffering with other disease(s) requiring long-term oral anticoagulation treatment;
  • Initial untreated AF, or secondary AF with clear cause (such as hyperthyroid heart disease);
  • Intracardiac thrombus (including left and/or right atrium) found or persisted;
  • Suffered with myocardial infarction within 3 months;
  • History of previous atrial septum repair operation or Atrial Septal Occluder implantation;
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  • History of previous heart valve (mechanical valve) replacement operation;
  • Subjects undergoing heart transplant operation;
  • Subjects with symptomatic carotid artery disease (such as carotid stenosis > 50%) or subjects with vulnerable carotid artery plaque.
  • Suffered with ischemic stroke or TIA recently (within 30 days);
  • Known complex active atherosclerotic plaque(s) in the descending aorta or aortic arch;
  • Severe heart failure (NYHA Grade Ⅳ);
  • The investigator assessed that there were abnormal result(s) with clinical significance in the routine blood test of subjects；
  • Severe renal abnormal: serum creatinine >250μmol/l; or on dialysis;
  • Allergic or contraindicated to aspirin, clopidogrel, heparin, contrast agent, and nitinol alloy;
  • Subjects who are scheduled to receive operation within 1 year after procedure, and need to stop anti-thrombotic therapy;
  • Pregnant or breast-feeding subjects, or subjects who plan to have a child within 1 year after procedure;
  • Subjects with a life expectancy less than 12 months;
  • Subjects who are participating in another investigational drug or device clinical trial in which the primary endpoint is still not reached before enrolment;
  • Subjects have other reasons that cannot maintain 2 months anticoagulation or 6 months dual antiplatelet therapy;
  • Subjects with poor compliance (judged by investigator) or cannot complete the study according to the protocol due to other reasons;
  • Subjects who are unsuitable to receive LAA occlusion treatment (judged by investigator).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Safety And EFficacy of Using LEft Atrium APpendage Closure in Nonvalvular AtRial FibrillatiOn PatienTs With High Risk of ischEmiC sTroke -- A Prospective Multicenter Randomized Clinical Trial

To evaluate the safety and efficacy of using Microport CardioAdvance Left Atrium Appendage Closure for preventing stroke in Non-valvular atrial fibrillation (NVAF) patients who have contraindications for long-term anti-coagulation. And to support registration approval from National Medical Products Administration (NMPA).

Read the detailed description

SAFE-PROTECT trial is composed of Roll-in group, small-size group and RCT group. This trial is planned to conduct in about 20 sites from China.

Roll-in group plans to enroll at most 3 subjects each site to implant experimental device for exploration and observation.

RCT group plans to enroll no less than 210 subjects who meet the inclusion/exclusion criteria, and 1:1 randomly allocated to experimental arm or comparator arm.

Being tested
Left atrial appendage closure procedure
Keywords
LAAC, NVAF, ischemic stroke
Medical subject headings
Atrial Fibrillation, Stroke, Ischemic Stroke

What participants receive

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

  • Left atrial appendage closure procedureDevice

    Implant LAAC system in LAA through percutaneous intervention

Study groups in NCT04479722
Study groupRoleWhat they receive
Microport CardioAdvance LAAC systemExperimentalSubject implant Microport CardioAdvance LAAC system to occlude LAA through percutaneous intervention.
Receives: Device: Left atrial appendage closure procedure
Watchman LAAC systemActive comparatorSubject implant Watchman LAAC system to occlude LAA through percutaneous intervention.
Receives: Device: Left atrial appendage closure procedure

What is being measured

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

  1. Clinical success

    Freedom from ischemic stroke, hemorrhagic stroke, systemic embolism, cardiovascular death and unexplained death

    Measured: 12-month

Secondary outcomes (1)

  1. LAA occlusion success

    TEE examination showing that the residual shunt < 5mm jet width or complete occlusion of LAA

    Measured: 12-month

Timeline

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

  1. First posted21 Jul 2020
  2. Study start3 Mar 2021
  3. Primary completion27 Sep 2022
  4. Study completion30 Sep 2026 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04479722
Sponsor's protocol ID
SAFE-PROTECT
Acronym
SAFE-PROTECT
Status last verified
Sep 2023
First submitted
16 Jul 2020
Last updated
23 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Additionally, study protocol will be available. The data will become available for the beginning 3 months and ending 5 years following article publication. If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.

Publications

  • Wang B, Cai H, Wu Y, Chen M, Wang C, Jiang X, Tao S, Zhong Z, Zeng J, Wang F, Ning Z, Yuan Z, He J, Francese DP, Lansky AJ, He B, Chu H, Of The Safe-Protect Investigators OB. Left atrial appendage closure with the AnchorMan or Watchman devices: 12-month results of the SAFE-PROTECT randomised trial. EuroIntervention. 2026 Jul 6;22(13):e720-e729. doi: 10.4244/EIJ-D-25-01168.

    PubMed 42405627

Questions about this trial

What is this clinical trial studying?

A study testing Left atrial appendage closure procedure in people with Atrial Fibrillation and Stroke, run by Shanghai MicroPort Medical (Group) 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 7 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 23 Oct 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?

Results are not available in the source record.

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?

Clinical success (time frame: 12-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 NCT04479722, which also lists 1 linked publication.

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 23 Oct 2023.

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