Status:
UNKNOWN
Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry
Lead Sponsor:
Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
Single-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.
Detailed Description
Detailed Description: Atrial fibrillation (AF) is the most common cardiac arrhythmia causing ischemic stroke. The CHA2DS2-VASc score was developed to estimate the stroke rate in patients with non-val...
Eligibility Criteria
Inclusion
- 1\. Patients must be at least 18 years of age; 2. Patients with non-valvular paroxysmal, persistent or permanent atrial fibrillation with long-term sustainability scheduled for interventional LAA closure; 3. Patient characteristics consistent with the corresponding IFU and sizing guidelines\*; 4. 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); 5. The patient agrees to comply with requirements of the study including the 24 months follow- up.
Exclusion
- 1\. Any contra-indication mentioned in the corresponding IFU\*; 2. Currently participating in other investigational drug- or device studies; 3. Patient who is pregnant, planning to become pregnant, or breast feeding; 4. Patients cannot tolerate transoesophageal echocardiogram (TEE).
- Note: In IFU, the Left Atrial Appendage Closure System is contraindicated for the following: • Patients' LAA anatomy not suitable for the REF of the device.
- Patients' with intracardiac thrombus.
- Patients with active endocarditis or other infections causing bacteremia.
- Patients where placement of the device would interfere with any intracardiac or intravascular structures.
- Patients with contraindications to X-Ray and/or trans-esophageal echocardiographic examinations.
- Patients with known hypersensitivity to nickel.
Key Trial Info
Start Date :
March 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04307927
Start Date
March 14 2020
End Date
December 31 2025
Last Update
November 29 2022
Active Locations (1)
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1
Katholisches Klinikum Koblenz ·Montabaur
Koblenz, Germany, 56073