FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients
Recruiting
N/A
Interventional Study
Non-valvular Atrial Fibrillation (NVAF)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 10 (estimated)
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
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About This Trial
To evaluate the preliminary safety and feasibility of the LAmbreTM II Left Atrial Appendage Occluder and the Occluder Delivery System in patients with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. The patient age ≥18 years;
2. The patient has documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation;
3. The patient has a CHA2DS2-VASc score of ≥ 2 in men and CHA2DS2-VASc score of ≥ 3 in women;
4. The patient is recommended for oral anticoagulation…
Contacts