Clinical trials: Atrial Appendage
Atrial Fibrillation (AF), Stroke
Elite AF IDE Trial (Elite AF)
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for…
- Trial name
- NCT07287436
- Testing
- WATCHMAN Elite LAAC Device
- Where
- 2 sites in United States
- Volunteers
- 400 people
- Sponsor
- Boston Scientific Corporation
Efficacy, Self, Safety Issues
I Can sEe Left Atrial Appendage (ICELAA) Clinical Study
The primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce…
- Trial name
- ICELAA (NCT04196335)
- Testing
- intra-procedural intracardiac echocardiography
- Where
- 7 sites in Denmark, Italy and 2 more
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Left Atrial Appendage Exclusion
CLIP-IT Post-Market Study
The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
- Trial name
- NCT06203054
- Testing
- Penditure™ Left Atrial Appendage (LAA) Exclusion System
- Where
- 15 sites in United States
- Volunteers
- 198 people
- Sponsor
- Medtronic Cardiac Surgery
Non-valvular Atrial Fibrillation
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study ( Europe Only)
Watchman FLX Left Atrial Appendage Closure Device Post Approval Study
- Trial name
- NCT02654470
- Testing
- Watchman FLX
- Where
- 17 sites in Denmark, France and 7 more
- Volunteers
- 300 people
- Sponsor
- Boston Scientific Corporation
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.
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
Atrial Fibrillation, Left Atrial Appendage
Zenith LAA Occlusion System
Demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage, Stroke
- Trial name
- NCT05951101
- Testing
- Zenith LAA Occlusion System
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 10 people
- Sponsor
- AuriGen Medical Ltd
Atrial Fibrillation
aMAZE Trial Continued Access Protocol
aMAZE CAP is an extension to the current aMAZE Trial investigation (IDEG150107/NCT02517397/Protocol Appendix 16) in the form of a nested, non-randomized registry, to allow ongoing treatment of subjects and the collection of…
- Trial name
- aMAZE CAP (NCT04468334)
- Testing
- LARIAT + PVI
- Where
- 25 sites in United States
- Volunteers
- 82 people
- Sponsor
- AtriCure, Inc.
Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation, LAA Anatomy Amenable to Treatment by Percutaneous Technique
Coherex WAVECREST I Left Atrial Appendage Occlusion Study
Purpose To establish the safety and efficacy of the Coherex WaveCrest Left Atrial Appendage Occlusion System for left atrial appendage (LAA) closure during treatment of non-valvular atrial fibrillation in patients who are at…
- Conditions
- Non-valvular Paroxysmal, Persistent, or Permanent Atrial Fibrillation, LAA Anatomy Amenable to Treatment by Percutaneous Technique, Anticoagulation Indication for Potential Thrombus Formation in the Left Atrium
- Trial name
- NCT02239887
- Testing
- WaveCrest LAA occlusion device
- Volunteers
- 155 people
- Sponsor
- Coherex Medical
Persistent Atrial Fibrillation
WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm
WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and effectiveness data on combining conventional AF ablation with LAA electric isolation and closure within a single procedure.
- Trial name
- WATCH-Rhythm (NCT03835338)
- Testing
- Pulmonary Vein Isolation, LAA Isolation, LAA Occlusion
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm.
- Trial name
- NCT00129545
- Testing
- WATCHMAN Left Atrial Appendage Closure Technology, Warfarin
- Where
- 62 sites in United States, Czechia and 1 more
- Volunteers
- 800 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
Amplatzer Amulet LAAO vs. NOAC
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for…
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- CATALYST (NCT04226547)
- Testing
- Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Non-Vitamin K Oral Antagonists
- Where
- 127 sites in United States, Australia and 14 more
- Volunteers
- 2,650 people
- Sponsor
- Abbott Medical Devices
Non-valvular Atrial Fibrillation (NVAF)
FIM Study of the LAmbre™ II LAA Occluder in Non-Valvular AF Patients
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…
- Trial name
- NCT07385599
- Testing
- LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System
- Where
- Hong Kong
- Volunteers
- 10 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., 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.
Left Atrial Appendage Absent
VCLIP Post-Market Study, Long-term Follow-up on LAA Exclusion Using AtriClip
Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial…
- Trial name
- VCLIP (NCT05101993)
- Testing
- AtriClip
- Where
- 11 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- AtriCure, Inc.
Stroke
AMPLATZER™ Amulet™ LAA Occluder Trial
The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial…
- Trial name
- Amulet IDE (NCT02879448)
- Testing
- Amulet Left Atrial Appendage Occluder, WATCHMAN Left Atrial Appendage Closure
- Where
- 115 sites in United States, Australia and 9 more
- Volunteers
- 1,878 people
- Sponsor
- Abbott Medical Devices
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
Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
Registry on WATCHMAN Outcomes in Real-Life Utilization
The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism.
- Trial name
- EWOLUTION (NCT01972282)
- Testing
- WATCHMAN Left Atrial Appendage Closure
- Where
- 47 sites in Belgium, France and 11 more
- Volunteers
- 1,025 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation
This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation.
- Trial name
- OLAAC (NCT02105584)
- Testing
- Implantation of LAA closure device
- Where
- 7 sites in Germany, United Kingdom
- Volunteers
- 78 people
- Sponsor
- Occlutech International AB
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