Clinical trials: Left Atrial Appendage Closure
Atrial Fibrillation
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients…
- Trial name
- OPTION (NCT03795298)
- Testing
- WATCHMAN FLX Implant, Market-approved OAC
- Where
- 114 sites in United States, Australia and 8 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Lifetech LAmbre™ Left Atrial Appendage (LAA) Closure System Post-Market Clinical Follow-up Study
Multi-center, single-arm, prospective, post-market study of LAmbre™ LAA Closure System. To evaluate the immediate and long-term procedural success of Lifetech LAmbre™ occluders in patients.
- Trial name
- LISA (NCT03666780)
- Testing
- LAmbre Occluder
- Where
- 26 sites in China, Denmark and 7 more
- Volunteers
- 500 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation
ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology
The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.
- Trial name
- ASAP (NCT00851578)
- Testing
- WATCHMAN
- Where
- 4 sites in Czechia, Germany
- Volunteers
- 150 people
- Sponsor
- Boston Scientific Corporation
Atrial Septal Defect, Atrial Fibrillation
Feasibility Study on the VERAFEYE System
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.
- Conditions
- Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure
- Trial name
- LUMINIzE (NCT05931835)
- Testing
- VERAFEYE System
- Where
- Ireland
- Volunteers
- 18 people
- Sponsor
- LUMA Vision Ltd.
Atrial Fibrillation
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that…
- Trial name
- NCT06099106
- Testing
- SEPIOLA System
- Where
- 5 sites in Georgia, Lithuania and 2 more
- Volunteers
- 15 people
- Sponsor
- Endomatic Ltd.
Atrial Fibrillation
LAmbre™ Left Atrial Appendage Closure System Follow-Up Study
The purpose of this study is to conduct a continuous telephone follow-up study on subjects who had completed the one-year follow-up of the LAmbre™ left atrial appendage (LAA) system registration trial.
- Trial name
- NCT03693092
- Where
- 11 sites in China
- Volunteers
- 156 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation, Left Atrial Appendage Closure
Registry on Luma Vision's VERAFEYE System (ENLIgHT)
The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure, Atrial Arrhythmia
- Trial name
- ENLIgHT (NCT06293430)
- Testing
- VERAFEYE System
- Volunteers
- 50 people
- Sponsor
- LUMA Vision Ltd.
Left Atrial Appendage Aneurysm
K2 Medical KALPA X™ Mapping, Imaging and Navigation Device
This prospective, multi-center, non-randomized, single-blinded, open-label, single-arm, comparator study will enroll up to 100 eligible subjects from multiple sites undergoing LAAC procedure to evaluate the safety and performance…
- Trial name
- NCT05155943
- Testing
- KALPA X™
- Where
- 2 sites in Italy, Lithuania
- Volunteers
- 18 people
- Sponsor
- Cara Medical Ltd
Atrial Fibrillation
Clinical Investigation of the LAmbre Left Atrial Appendage Closure System
The aim of the study LA-EU-01 was to examine the safety and the feasibility of the LAmbreTM Left Atrial Appendage Closure System in patients with non-valvular paroxymal, persistent or permanent atrial fibrillation, by using…
- Trial name
- NCT03122028
- Testing
- LAA closure system
- Volunteers
- 61 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation (AF)
COCONUT Study Concomitant PVI and LAAC
In patients with non-valvular AF, at high stroke risk, and who are ineligible for long-term oral anticoagulation LAAC could be an alternative to anticoagulation and safety and efficacy has been shown in several studies and…
- Trial name
- COCONUT (NCT06861673)
- Testing
- Pulmonary vein isolation
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Asklepios proresearch
Atrial Fibrillation, Stroke
Using Left Atrium Appendage Closure in NVAF Patients With High Risk of Ischemic Stroke
To evaluate the safety and efficacy of using Microport CardioAdvance Left Atrium Appendage Closure for preventing stroke in Non-valvular atrial fibrillation (NVAF) patients who have contraindications for long-term…
- Trial name
- SAFE-PROTECT (NCT04479722)
- Testing
- Left atrial appendage closure procedure
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Cardiac Arrythmias, Left Atrial Appendage Closure
Agilis RF TSP Early Feasibility Study
This study is a prospective, acute, first-in-human, early feasibility study intended to assess the initial safety and performance of the Agilis™ Radiofrequency (RF) Transseptal (TSP) System in crossing the atrial septum for left…
- Trial name
- NCT07361445
- Testing
- Transseptal procedure with Agilis RF TSP System.
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
Nonvalvular Atrial Fibrillation
First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder
This is the first in man study of E-SeaLATM developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd, which can achieve pulsed field ablation and mechanical closure of the Left Atrial Appendage simultaneously, this…
- Trial name
- NCT05731882
- Testing
- E-SeaLA, CardioPulse PFA system
- Where
- 3 sites in China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Dinova EP Technology Co., Ltd
Concomitant Procedures, Atrial Fibrillation
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and…
- Conditions
- Concomitant Procedures, Atrial Fibrillation, PFA, LAAC
- Trial name
- OPTION-A (NCT06686485)
- Testing
- FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
- Where
- 37 sites in China, Hong Kong and 4 more
- Volunteers
- 433 people
- Sponsor
- Boston Scientific Corporation
Left Atrial Appendage Occlusion
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA
- Trial name
- NCT00841529
- Testing
- Medtronic LAA Occlusion Device
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Medtronic Cardiovascular
Atrial Fibrillation (AF), Bleeding
Concomitant PFA Bsaed PVI Plus LAAC
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy…
- Conditions
- Atrial Fibrillation (AF), Bleeding, Stroke
- Trial name
- COCONUT_2 (NCT07450755)
- Testing
- Interventional LAA Closure, Pulmonary vein isolation
- Volunteers
- 150 people
- Sponsor
- Asklepios proresearch
Atrial Fibrillation Non-Rheumatic
A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W
The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism in Japanese Clinical environment
- Trial name
- SALUTE (NCT03033134)
- Testing
- BSJ003W
- Where
- 10 sites in Japan
- Volunteers
- 54 people
- Sponsor
- Boston Scientific Japan K.K.
Atrial Fibrillation
Lifetech LAmbre™ Left Atrial Appendage Closure System Post-Market Registry
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.
- Trial name
- NCT04307927
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Atrial Fibrillation, Left Atrial Appendage Closure
Data Collection for Echocardiography-Based Software Assessment
This is a prospective, observational study collecting data from routine clinical care. The information gathered will be used to support the evaluation of a software-based tool.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure, Cardiovascular Diseases
- Trial name
- NCT07126600
- Testing
- No investigational intervention administered
- Where
- 6 sites in United States
- Volunteers
- 100 people
- Sponsor
- Anumana, Inc.
Atrial Fibrillation, Stroke
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.
- Trial name
- PREVAIL (NCT01182441)
- Testing
- WATCHMAN Device, Warfarin
- Where
- 41 sites in United States
- Volunteers
- 407 people
- Sponsor
- Boston Scientific Corporation