NCT02937025

Brief 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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2017

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

1.4 years

First QC Date

October 14, 2016

Last Update Submit

October 14, 2016

Conditions

Non-valvular Atrial FibrillationStroke

Keywords

Nonvalvular atrial fibrillationStrokeLeft Atrial Appendage ClosureIntervention

Outcome Measures

Primary Outcomes (2)

  • Ischemic stroke

    12 months

  • Successful sealing of the LAA

    TEE Criteria

    12 months

Secondary Outcomes (3)

  • Component events

    12 months

  • Complication at puncture site

    12 months

  • Device performance assessed by TEE/TTE

    12 months

Study Arms (1)

Left Atrial Appendage Closure Device Group

EXPERIMENTAL

Device:LAmbre Left Atrial Appendage Occluder（Shanghai Push Medical Device Technology CO.td） to close the left atrial appendage

Device: The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td

Interventions

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

Implanting the Occluder to close the left atrial appendage

Left Atrial Appendage Closure Device Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 19683639BACKGROUND

  • 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.

    PMID: 23325525BACKGROUND

  • 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.

    PMID: 24998121BACKGROUND

  • 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.

    PMID: 25399274RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yawei Xu, MD, PHD

    Shanghai 10th People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuang Li, MD

CONTACT

086-159217993511210874@tongji.edu.cn

Wei Chen, MD, PHD

CONTACT

086-21-6630818218917684083@189.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. and Pros.

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 18, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2018

Study Completion

January 1, 2020

Last Updated

October 18, 2016

Record last verified: 2016-10