View clinical trials related to Left Atrial Appendage Occlusion.
Filter by:The objective of this trial is to compare two different commercially available left atrial appendage occlusion (LAAO) devices in patients with non-valvular Atrial fibrillation/ atrial flutter (AF) at increased risk for stroke with regard to safety and efficacy. The investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is peri-device leak (PDL) size 3 months after LAAO, as assessed with transesophageal echocardiography (TOE) in patients with non-valvular AF.
The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism.
Objective: To demonstrate superiority of a strategy of anticoagulation with apixaban 5mg/2.5mg bid as compared with the current standard of care (dual antiplatelet therapy) after occlusion of the left atrial appendage (LAAC) in patients with atrial fibrillation (AF). Rationale: Data on antithrombotic therapy after LAAC are scarce and no randomized evaluation has been performed to demonstrate what is the best antithrombotic strategy. LAAO in patients without contraindication to chronic anticoagulants (PROTECT-AF regimen) is a 6-week period of anticoagulation with warfarin associated with aspirin, followed by once daily clopidogrel (75 mg) and aspirin (81-325 mg) until the 6 months visit, then aspirin alone is continued indefinitely, as tested in the pivotal trials. LAAO is also being used as an alternative to warfarin anticoagulation when patients have a contraindication or are unsuitable to warfarin. These patients usually receive a regimen of daily clopidogrel and aspirin (DAPT) for 3 months. Some may receive a shorter duration of DAPT or even only single antiplatelet therapy (SAPT) in case of excess bleeding risk. This antiplatelet regimen has never been compared with any anticoagulation regimen after LAAC. The Investigators propose to evaluate a unique antithrombotic strategy after LAAC for atrial fibrillation, whatever the indication of LAAC, including patients not suitable for long term warfarin anticoagulation. This strategy uses apixaban 5mg (with dose adjustment when necessary) which will be compared to the standard of care based on antiplatelet therapy and which may vary according to the risk profile of the patient. Apixaban, has demonstrated a mortality benefit associated with significant reductions in stroke, systemic embolism and major bleeding versus VKA. In addition, apixaban is the only NOAC which has demonstrated superiority over aspirin alone, in AF patients not suitable for chronic warfarin anticoagulation, to prevent cardio-embolic events with a safety profile similar to aspirin.The Investigators therefore formulate the hypothesis that apixaban is superior to standard of care (APT) to prevent cardiovascular events and bleeding complications after LAAO. Population: Inclusion criteria: AF patients who have undergone a successful LAAO procedure. Exclusion criteria include any indication for triple antithrombotic treatment, mechanical heart valve, use of prasugrel or ticagrelor, serious renal failure defined as a creatinine clearance <15mL/min, contraindication to any form of anticoagulation or antiplatelet therapy. Randomization will occur always before hospital discharge as soon as the patient is stable or stabilized after the procedure. Randomization: Apixaban vs. APT, both for 3 months. Groups: 1/Apixaban 5mg or 2.5mg bid (if dose adjustment needed). 2/ DAPT using low-dose ASA (75-100mg) and clopidogrel (75mg); or in patients with a history of intracranial hemorrhage (ICH) SAPT (aspirin or clopidogrel) will be used instead of DAPT from the time of randomization. Follow-up: 12 months from randomization Primary endpoint: combined enpoint of death, MI, stroke, thromboembolic complications, major or significant bleeding at 3 months follow-up. Sample size: In order to find a 16% difference in the event rates among the two treatment strategies, using a logrank test with a 5% two-sided significance level, we will need 76 patients in each group (152 in total). However, to compensate patient drop out, a total of 160 patients will be included in the study. Recruitment : 24 months Centers: 3 centers in Spain.
The study will perform a randomized, head-to-head comparison between SAPT (aspirin) and DAPT (aspirin plus clopidogrel) after percutaneous LAA closure with implantation of the Amulet device (AbbottTM, Abbott Park, Illinois, US) in patients with AF. Primary outcome measure will be a net composite endpoint at 6 months including all-cause death, DRT, clinically relevant bleeding complications and ischemic events. The SAPT arm will receive aspirin alone up to 6 months, while the DAPT arm will receive DAPT for 3 months and then aspirin alone. Thus, between 3- and 6-month follow-up both groups will be given aspirin alone.
LAAOS III Extension is a longer term follow-up of an international cohort study of patients who were enrolled in the Left Atrial Appendage Occlusion Study (LAAOS III) trial.
The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance.
This project intends to enroll patients with persistent atrial fibrillation who are planning to undergo catheter ablation of atrial fibrillation. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. We are intend to evaluate the safety and effectiveness of one-stop operation of left atrial appendage electrical isolation combined with left atrial appendage occlusion in the treatment of persistent atrial fibrillation.
A total of 60 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. The diameter and depth of the left atrial appendage opening were measured by angiography in group A(ICE group), and measured by ICE in group B(radiography group). The size of the occluder device was selected according to the measurement size of the two groups, the occluder device success rate of the two groups was compared, and the relationship between measurement size and the size of the occluder device was obtained.
A total of 40 patients with atrial fibrillation were scheduled to receive left atrial appendage occlusion, which were divided into two groups. The operation was performed under the guidance of intracardiac echocardiography and left atrial appendage radiography, respectively (allocation ratio 1:1). During the operation, the total amount of contrast medium injected, the fluoroscopy time and the time from femoral vein puncture to transseptal puncture to closure were recorded in all patients. The diameter and depth of the left atrial appendage opening were measured by angiography in group A(ICE group), and measured by ICE in group B(radiography group). The size of the occluder device was selected according to the measurement size of the two groups, the occluder device success rate of the two groups was compared, and the relationship between measurement size and the size of the occluder device was obtained.
Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.