Atrial Fibrillation
Conditions
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.
Interventions
None listed
Sponsors
Lifetech Scientific (Shenzhen) Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of compound event | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of stroke | 2,3,4,5 years postoperative follow-up | Stroke is deviated into ischemic, hemorrhagic or undetermined stroke, and transient ischemic attacks (TIA). |
| The incidence of MACCE events | 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 | 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 event of bleeding | 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 | 2,3,4,5 years postoperative follow-up | Non-fatal myocardial infarction, arrhythmia, cardiac tamponade, cardiogenic shock, endocarditis. |
Countries
China
Contacts
Primary ContactYing Xia
Outcome results
None listed