Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up
About the study
Multi-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate immediate and long term procedural success of Lifetech LAmbre™ occluders in patients.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Patients must be at least 18 years of age;
- Patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability scheduled for interventional LAA closure;
- Patient characteristics consistent with the corresponding IFU and sizing guidelines;
- The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Committee (EC);
The patient agrees to comply with requirements of the study including the 3 year follow-up.
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EXCLUSION CRITERIA
Exclusion Criteria:
- Any contra-indication mentioned in the corresponding IFU;
- Currently participating in other investigational drug- or device studies;
- Patient who is pregnant, planning to become pregnant or breast feeding;
- Patients cannot tolerate transoesophageal echocardiogram (TEE).
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Atrial Fibrillation
Age (in years)
18+
Participants needed
500
Est. Completion Date
Nov 30, 2024
Treatment type
Observational
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
ClinicalTrials.gov identifier
NCT03666780
Study number
LA-PMCF-01
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