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AzTrials

Non-valvular Atrial FibrillationPhase 1/2NCT02937025

Study of Safety and Efficacy of a Left Atrial Appendage Occulder

A Phase 1/2 study testing The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td in people with Non-valvular Atrial Fibrillation and Stroke, run by Ya-Wei Xu.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study mainly evaluated the feasibility and safety of a kind of Left Atrial Appendage Occluders which is to prevent ischemic stroke caused by nonvalvular atrial fibrillation (AF) Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Non-valvular Atrial Fibrillation, Stroke
What is being tested?
The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
No sites listed yet
Study dates
Jan 2017to Jan 2020
Phase
Phase 1/2
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

  • Patient is ≥18 years of age;
  • Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
  • CHADS2-VAS score 2 or higher，HAS-BLED score 3 or higher;
  • Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
  • Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.

Who cannot join

  • A. Clinical exclusion criteria： Presence of rheumatic, degenerative or congenital valvular heart diseases, The diameter of left atrial ≥65 mm; LAA size < 12mm or > 30 mm Left atrium has been removed; Heart transplantation patients; Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%); Acute myocardial infarction or unstable angina; Decompensated heart failure (New York Heart Association functional class III-IV); Recent myocardial infarction (< 3 months); Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder Patient who after artificial mechanical heart valve replacement operation; Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days; Presence of complex aortic plaque(4mm) in ascending aorta; Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years; Have thrombocytopenia (platelet 《105 / μl) or anemia（Hb<10g/dl）; Women who is pregnancy or plan to pregnancy during the trial period; Presence of active sepsis or endocarditis; Patient participated in the other trials; The investigators expect the patient not be able to complete the trial according to requirements.
  • Esophageal ultrasonic exclusion criteria： LVEF≤30%; Presence of left atrial appendage thrombus; High risk PFO patients(presence of atrial septal aneurysm); Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2); Have obvious and unexplained pericardial effusion(≥4 cm2). Presence of complex aortic plague(≥4 mm) in ascending aorta.

Trial locations and contacts

No sites are listed yet.

Shuang Li, MD contact

086-15921799351

1210874@tongji.edu.cn

Wei Chen, MD, PHD contact

086-21-66308182

18917684083@189.cn

About this study

This study mainly evaluated the feasibility and safety of a kind of Left Atrial Appendage Occluders which is to prevent ischemic stroke caused by nonvalvular atrial fibrillation (AF)

Read the detailed description

Atrial fibrillation (AF) is a common arrhythmia, its incidence increases with age. Thrombosis shed off caused by AF is one of the major causes of stroke. Most patients with AF suffer ischemic stroke that the thrombosis was from the left atrial appendage(LAA). The majority of patients with atrial fibrillation, the blood clots come from the left atrial appendage, so close the left atrial appendage can reduce cycle thromboembolism of the patients with AF. Now patients have cardiac surgery and risk at left atrium related thromboembolism, the surgery has been conventional perform the left atrial appendage closed surgery.

However, surgical left atrial appendage ligation is difficult to be completely closed to the left atrial appendage,internal medicine intervention methods of surgical closure the left atrial appendage is relatively simple, minimally invasive, high success rate and is expected to be widely used.

Several versions of LAA occlusion devices have been developed.LAA occluder of Shanghai Push Medical Device Technology CO.td, consists of a fixed ball and a cover; The fixed ball composed of multiple umbrella and covered the ePTFE membrane.This study mainly evaluated the feasibility and safety of the new Left Atrial Appendage Occluder! Through the femoral vein puncture; insert inter atrial septum puncture device; puncture a small hole in the atrial septal, delivery sheath is inserted in the femoral vein puncture site and across the atrial septal reach the left atrial appendage, establishment of the channel. Through the built-channel sent the LAA occluder to the left atrial appendage by the delivery cable; The LAA occlude will be fixed in the left atrial appendage, close the entrance of the left atrial appendage meanwhile and block blood flow; then eliminate the risk of blood clots due to atrial fibrillation, prevention stroke.

Being tested
The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td
Keywords
Nonvalvular atrial fibrillation, Stroke, Left Atrial Appendage Closure, Intervention
Medical subject headings
Stroke

What participants receive

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

  • The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.tdDevice

    Implanting the Occluder to close the left atrial appendage

Study groups in NCT02937025
Study groupRoleWhat they receive
Left Atrial Appendage Closure Device GroupExperimentalDevice:LAmbre Left Atrial Appendage Occluder（Shanghai Push Medical Device Technology CO.td） to close the left atrial appendage
Receives: Device: The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td

What is being measured

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

  1. Ischemic stroke

    Measured: 12 months

  2. Successful sealing of the LAA

    TEE Criteria

    Measured: 12 months

Secondary outcomes (3)

  1. Component events

    death, thromboembolism, device related complication and MACCE

    Measured: 12 months

  2. Complication at puncture site

    Measured: 12 months

  3. Device performance assessed by TEE/TTE

    Measured: 12 months

Timeline

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

  1. First posted18 Oct 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJun 2018 (estimated)
  4. Study completionJan 2020 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02937025
Sponsor's protocol ID
CP0010
Status last verified
Oct 2016
First submitted
14 Oct 2016
Last updated
18 Oct 2016
Results posted
No

Publications

  • Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X.

    PubMed 19683639

  • Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.

    PubMed 23325525

  • Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.

    PubMed 24998121

  • Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.

    PubMed 25399274

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td in people with Non-valvular Atrial Fibrillation and Stroke, run by Ya-Wei Xu.

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 5 inclusion and 2 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 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Shuang Li, MD (086-15921799351, 1210874@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ischemic stroke (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02937025, which also lists 4 linked publications.

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 18 Oct 2016.

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