LAmbre™ Left Atrial Appendage Closure System Follow-Up Study
1 other identifier
observational
156
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedStudy Start
First participant enrolled
November 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedOctober 2, 2018
September 1, 2018
1.4 years
September 30, 2018
September 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of compound event
The compound event including death, systemic embolization, complications related to the device and requiring treatment (cardiac embolism, embolization, stroke, hemorrhage, death).
5 years after the surgery
Secondary Outcomes (5)
The incidence of MACCE events
2,3,4,5 years postoperative follow-up.
Ischemic stroke rate
2,3,4,5 years postoperative follow-up
The rate of stroke
2,3,4,5 years postoperative follow-up
The event of bleeding
2,3,4,5 years postoperative follow-up
Cardiac events
2,3,4,5 years postoperative follow-up
Eligibility Criteria
Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.
You may qualify if:
- \- Patients who participated in the LAmbreTM Safety and Efficacy Study and completed the 1-year follow-up.
- Age\>=18, CHADS2 score\>=1
- Patients cannot be treated long-term with Warfarin
- Eligible for clopidogrel and aspirin
- Provide written informed consent and agree to comply with the required follow-ups
You may not qualify if:
- Need to take Warfarin
- Presence of rheumatic, degenerative or congenital valvular heart diseases
- Early stage or paroxysmal atrial fibrillation
- Symptomatic patients with carotid artery disease (such as carotid stenosis\>=50%)
- Heart failure NYHA grade IV
- Recent 30 days stroke or TIA
- Presence of active sepsis or endocarditis
- Cardiac tumours or other malignancy with estimated life expectancy \<2 years
- Abnormal blood test; renal dysfunction
- LAA removed or heart implant patients
- Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
- Patients have a history of mechanical prosthesis operation
- Patients who are pregnant, or desire to be pregnant during the during the study
- Participation in other trials
- A known allergy to nitinol
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Beijing Chaoyang Hospital, Capital Medical university
Beijing, Beijing Municipality, China
Fuwai Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Shandong, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Congxin Huang
People's Hospital of Wuhan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2018
First Posted
October 2, 2018
Study Start
November 20, 2018
Primary Completion
April 1, 2020
Study Completion
July 1, 2020
Last Updated
October 2, 2018
Record last verified: 2018-09