Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take W… (NCT02029014) | Clinical Trial Compass
UnknownPhase 3
Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin
China154 participantsStarted 2014-03
Plain-language summary
The aim of this study is to assess the efficacy, safety and performance of LAmbre left atrial appendage closure system in patients with non-valvular atrial fibrillation who cannot be treated with Warfarin.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age\>=18, CHADS2 score\>=1
* Patients cannot be treated long-term with Warfarin
* Eligible for clopidogrel and aspirin
* Provide written informed consent and agree to comply with required follow-ups
Exclusion Criteria:
* Need to take Warfarin
* Presence of rheumatic, degenerative or congenital valvular heart diseases
* Early stage or paroxysmal AF
* Symptomatic patients with carotid artery disease (such as carotid stenosis\>=50%)
* Heart failure NYHA grade IV
* Recent 30 days stroke or TIA
* Presence of active sepsis or endocarditis
* Cardiac tumors or other malignancy with estimated life expectancy \<2 years
* Abnormal blood test; renal disfunction
* LAA removed or heart implant patients
* Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system
* Patients have history of mechanical prosthesis operation
* Patients who are pregnant, or desire to be pregnant during the during the study
* Participation in other trials
* A known allergy to nitinol
* Patients will not be able to complete the trial
Esophageal ultrasonic exclusion criteria:
* LAA Ostium \<=12mm or \>=30mm
* LVEF \<30%
* Presence of thrombus in the heart
* High risk PFO
* Mitral valve stenosis (valve area \<2 cm2