Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT03693092
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03693092
Study Brief:
Protocol Section:
NCT03693092