Clinical trial NCT03693092: LAmbre™ Left Atrial Appendage Closure System Follow-Up Study
Official title: LAmbre™ Left Atrial Appendage Closure System Post-Market 2-5 Years Follow-Up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of compound event
timeFrame: 5 years after the surgery
Secondary outcomes:
measure: The incidence of MACCE events
timeFrame: 2,3,4,5 years postoperative follow-up.
measure: Ischemic stroke rate
timeFrame: 2,3,4,5 years postoperative follow-up
measure: The rate of stroke
timeFrame: 2,3,4,5 years postoperative follow-up
measure: The event of bleeding
timeFrame: 2,3,4,5 years postoperative follow-up
measure: Cardiac events
timeFrame: 2,3,4,5 years postoperative follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical university
state: Beijing
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academy of Medical Science
state: Beijing
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: People's Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military Region
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
Study officials:
affiliation: People's Hospital of Wuhan University
name: Congxin Huang
role: PRINCIPAL_INVESTIGATOR
References: