LAmbre™ Left Atrial Appendage Closure System Follow-Up Study

LifeTech Scientific

Status: Unknown

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT03693092

LAA 2-5ys FU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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