Clinical trials: Left Atrial Appendage Closure, open to volunteers
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
Ischemic Stroke, Atrial Fibrillation
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF.
- Trial name
- ELAPSE (NCT05976685)
- Testing
- Left atrial appendage Occlusion, DOAC
- Where
- 33 sites in Belgium, Germany and 4 more
- Volunteers
- 482 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Atrial Fibrillation
The Role of Multimodality Imaging in Left Atrial Appendage Closure
The aim of the present prospective, randomized single-centre study is to examine the success rate, safety, overall preoperative and operative burden and long-time outcome of percutaneous left atrial appendage closure procedures…
- Trial name
- MILAAC (NCT04800913)
- Testing
- Multimodal imaging, Standard imaging
- Where
- Hungary
- Volunteers
- 44 people
- Sponsor
- Hungarian Institute of Cardiology
Atrial Fibrillation, Left Atrial Appendage Absent
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Left atrial appendage (LAA) closure has become a frequent addition to oral anticoagulation in patients with atrial fibrillation who undergo cardiac surgery.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Absent, Anticoagulant Adverse Reaction
- Trial name
- NCT06401616
- Testing
- OAC will be discontinued for the duration of the trial
- Where
- 6 sites in Denmark
- Volunteers
- 1,220 people
- Sponsor
- Odense University Hospital
Non-valvular Atrial Fibrillation, Embolic Stroke
Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System.
- Trial name
- NCT04559243
- Testing
- Transthoracic Echocardiography
- Where
- 5 sites in China
- Volunteers
- 579 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Left Atrial Appendage Closure
Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral
A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized 1:1 to the best medical treatment (control) or the combination of LAAO and DOAC or OAC.
- Trial name
- ADDLAAO (NCT06869811)
- Testing
- LAA Closurse
- Where
- Spain
- Volunteers
- 380 people
- Sponsor
- Hospital Clinic of Barcelona
Acute Ischemic Stroke AIS, Stroke Treatment
CardioLogical Interventions and Acute strOke Treatment sTudy
The study aims to investigate characteristics and prognosis of ischemic stroke cases following cardiological interventions, focusing on the effectiveness and safety of acute ischemic stroke treatments.
- Conditions
- Acute Ischemic Stroke AIS, Stroke Treatment, PCI Patients, Aortic Valve Replacement
- Trial name
- CLOT (NCT07314476)
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- University of L'Aquila
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
OPTION-EMEA Clinical Trial
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with…
- Conditions
- Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation
- Trial name
- OPTION-EMEA (NCT07349121)
- Testing
- Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
- Where
- 11 sites in Belgium, Croatia and 3 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Nonvalvular Atrial Fibrillation
TEE-Guided Versus CCTA-Guided Preprocedural Imaging for Left Atrial Appendage Closure
This prospective, open-label, multicenter randomized controlled trial will compare two preprocedural imaging assessment strategies in adults with nonvalvular atrial fibrillation who are scheduled to undergo percutaneous left…
- Trial name
- PEARL-LAAC (NCT07815119)
- Testing
- Transesophageal Echocardiography-Guided Preprocedural Assessment, Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment
- Where
- China
- Volunteers
- 590 people
- Sponsor
- Shanghai Zhongshan Hospital
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
Atrial Fibrillation
Surgical vs Percutaneous LAAO
Atrial fibrillation is the most common cardiac arrythmia globally. Its prevalence ranges between 2-4% worldwide. It is associated with significant morbidity and mortality.
- Trial name
- NCT05420701
- Testing
- TEE
- Volunteers
- 260 people
- Sponsor
- Chinese University of Hong Kong
Coronary Artery Disease
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure
Clinical investigation with CE-marked medical devices, multicenter, prospective, randomized and controlled. Patients with non-valvular atrial fibrillation at high embolic risk and with at least one high bleeding risk criterion…
- Trial name
- CALAMBRE (NCT07260474)
- Testing
- Patients implanted with Amplatzer Amulet™, Patients implanted with LAmbre™
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- Fundación EPIC
Atrial Fibrillation, Stroke
Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET
The novel Amplatzer steerable delivery sheath (Abbott Vascular) is found to be safe and effective in performing LAAO procedure. However, the procedural outcomes have not been compared with the traditional non-steerable fixed…
- Trial name
- NCT05464511
- Testing
- Left atrial appendage occlusion with the dual mechanism closure Amulet device using a novel steerable sheath.
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- Kansas City Heart Rhythm Research Foundation
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, 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.
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.
Left Atrial Appendage Thrombosis
The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery.
This study aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing open heart surgery, regardless of their…
- Trial name
- NCT06172738
- Testing
- the left atrial appendage closure through surgery.
- Volunteers
- 100 people
- Sponsor
- Assiut University
Left Atrial Appendage Closure
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal…
- Trial name
- ICETEE (NCT06348394)
- Testing
- Intracardiac Echocardiography, Traditional transesophageal echocardiography
- Where
- United States
- Volunteers
- 444 people
- Sponsor
- Baylor Research Institute
Atrial Fibrillation, Arrhythmias, Cardiac
Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion
This study is a prospective, multi-center, randomized controlled trial. The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation (AF) ablation and left atrial appendage (LAA) occlusion.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT06455644
- Testing
- CT group, DSA group
- Where
- 5 sites in China
- Volunteers
- 238 people
- Sponsor
- First Affiliated Hospital of Shantou University Medical College
Atrial Fibrillation
Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure
SAFE-LAAC Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device
- Trial name
- SAFE-LAAC (NCT03445949)
- Testing
- short postimplantation dual antiplatelet therapy, extended postimplantation dual antiplatelet therapy, long-term treatment with a single antiplatelet agent
- Where
- Poland
- Volunteers
- 200 people
- Sponsor
- National Institute of Cardiology, Warsaw, Poland