LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 30, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

November 20, 2018

Estimated Primary Completion Date

April 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The incidence of compound event[ Time Frame: 5 years after the surgery ]

The compound event including death, systemic embolization, complications related to the device and requiring treatment (cardiac embolism, embolization, stroke, hemorrhage, death).

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

The incidence of MACCE events[ Time Frame: 2,3,4,5 years postoperative follow-up. ]
The MACCE events including death (All cause death, All-cause death includes cardiac death, non-cardiac death and unexplained death), stroke, cardiac tamponade, and renal failure.
Ischemic stroke rate[ Time Frame: 2,3,4,5 years postoperative follow-up ]
Ischemic stroke is a neurological deficit caused by transient ischemic attack, cerebral thrombosis or cerebral embolism.
The rate of stroke[ Time Frame: 2,3,4,5 years postoperative follow-up ]
Stroke is deviated into ischemic, hemorrhagic or undetermined stroke, and transient ischemic attacks (TIA).
The event of bleeding[ Time Frame: 2,3,4,5 years postoperative follow-up ]
Intracranial or alimentary canal, or any bleeding that requires transfusion of 2 units of red blood cell suspension.
Cardiac events[ Time Frame: 2,3,4,5 years postoperative follow-up ]
Non-fatal myocardial infarction, arrhythmia, cardiac tamponade, cardiogenic shock, endocarditis.

Descriptive Information

Brief Title ^ICMJE

LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

Official Title ^ICMJE

LAmbre™ Left Atrial Appendage Closure System Post-Market 2-5 Years Follow-Up Study

Brief Summary

The purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the LAmbre™ left atrial appendage (LAA) system registration trial. The follow-up time was 2 years, 3 years, 4 years and 5 years after left atrial appendage closure operation, to evaluate the long-term safety and effectiveness of LAmbre™ LAA Closure System.

Detailed Description

All subjects who completed 1-year follow-up of the LAmbreTM LAA system registration trial will be conducted 2 years, 3 years, 4 years and 5 years follow-up by the telephone call. During the follow-up, the investigator or his/her designee will use a standardized form to record the occurrence of the subject's safety events and validity endpoint by telephone，and complete the safety and efficacy summary report. The endpoints of the study included compound events, MACCE events, stroke, haemorrhage and other events.

Study Type ^ICMJE

Observational [Patient Registry]

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational [Patient Registry]
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

156

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2020

Estimated Primary Completion Date

April 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up. The inclusion criteria of LAmbreTM Safety and Efficacy Study: 1. Age>=18, CHADS2 score>=1 2. Patients cannot be treated long-term with Warfarin 3. Eligible for clopidogrel and aspirin 4. Provide written informed consent and agree to comply with the required follow-ups Exclusion Criteria: - Exclusion criteria: Patients who did not participate in the LAmbreTM Safety and Efficacy Study or did not complete 1-year follow-up LAmbreTM Safety and Efficacy Study. The exclusion criteria of LAmbreTM Safety and Efficacy Study: 1. Need to take Warfarin 2. Presence of rheumatic, degenerative or congenital valvular heart diseases 3. Early stage or paroxysmal atrial fibrillation 4. Symptomatic patients with carotid artery disease (such as carotid stenosis>=50%) 5. Heart failure NYHA grade IV 6. Recent 30 days stroke or TIA 7. Presence of active sepsis or endocarditis 8. Cardiac tumours or other malignancy with estimated life expectancy <2 years 9. Abnormal blood test; renal dysfunction 10. LAA removed or heart implant patients 11. Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system 12. Patients have a history of mechanical prosthesis operation 13. Patients who are pregnant, or desire to be pregnant during the during the study 14. Participation in other trials 15. A known allergy to nitinol 16. Patients will not be able to complete the trial

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Lifetech Scientific (Shenzhen) Co., Ltd.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Congxin Huang People's Hospital of Wuhan University

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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