Clinical trials: Left Atrial Appendage Closure
Atrial Fibrillation, Left Atrial Appendage Closure
Austrian Left Atrial Appendage Closure Registry
Left atrial appendage (LAA) occlusion (LAAC) has been introduced to treat patients with indication of oral anticoagulation (OAC) for atrial fibrillation (AF) with contraindication to OAC.
- Trial name
- NCT03409159
- Testing
- LAAC
- Where
- Austria
- Volunteers
- 200 people
- Sponsor
- Medical University of Graz
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
- 5 sites in Belgium, Croatia and 3 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
WATCHMAN FLX Pro European Registry
The WATCHMAN FLX Pro European registry is intended to gather real world clinical data for patients undergoing left atrial appendage closure (LAAC) with the WATCHMAN FLX™ Pro device.
- Trial name
- NCT07262255
- Testing
- Left atrial appendage closure
- Where
- 20 sites in Denmark, Germany and 4 more
- Volunteers
- 189 people
- Sponsor
- Boston Scientific Corporation
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 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
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
Atrial Fibrillation, Stroke Prevention in Patients With Atrial Fibrillation
CLOT-LESS - CLOsure Tailored: LEss Antithrombotic Strategy After LAAC for Stroke Prevention
This is a prospective, non-randomized, observational cohort study conducted at the FSBI "NMRC TPM" of the Ministry of Healthcare of the Russian Federation.
- Conditions
- Atrial Fibrillation, Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Hemorrhage
- Trial name
- CLOT-LESS (NCT07575867)
- Testing
- Left Atrial Appendage Closure, Apixaban 2.5 mg BID, Standard-dose DOAC
- Where
- Russia
- Volunteers
- 464 people
- Sponsor
- National Medical Research Center for Therapy and Preventive Medicine
Left Atrial Appendage Closure, Thrombosis
Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure
The objective of the study is to compare short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.
- Conditions
- Left Atrial Appendage Closure, Thrombosis, Stroke, TIA
- Trial name
- ANDES (NCT03568890)
- Testing
- Rivaroxaban, dabigatran, apixaban, or edoxaban, Clopidogrel -75 mg/day, Low dose aspirin -80 to 125 mg/day-
- Where
- Canada
- Volunteers
- 510 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Transcatheter Left Atrial Appendage Closure, Frailty
Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.
To assess the prevalence and severity of frailty in patients undergoing LAAC, as well as its association to peri-procedural and long-term outcomes and quality of life.
- Trial name
- Frail-LAAC (NCT05257954)
- Where
- Canada
- Volunteers
- 500 people
- Sponsor
- Josep Rodes-Cabau
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.
Left Atrial Appendage Closure
Preventing Neurologic Complications in Valve Surgery
In patients with valvular heart disease and atrial fibrillation (AF) undergoing surgical valve surgery, current guidelines recommend concomitant surgical management of the left atrial appendage (LAA) to prevent postoperative…
- Trial name
- NCT07382362
- Testing
- Left Atrial Appendage (LAA) Suture Closure, Surgical Valve Surgery
- Where
- 4 sites in China
- Volunteers
- 100 people
- Sponsor
- China National Center for Cardiovascular Diseases
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, 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.
Nonvalvular Atrial Fibrillation, Aspirin
Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure
The goal of this clinical trial is to verify that Non-Antithrombotic Therapy (NAPT) followed by Oral Anticoagulants (OAC) monotherapy for 45 days after Left Atrial Appendage Closure (LAAC) is non-inferior to Single Antiplatelet…
- Conditions
- Nonvalvular Atrial Fibrillation, Aspirin, Non-Antithrombotic Therapy, High Bleeding Risk
- Trial name
- NCT07125417
- Testing
- Single Antiplatelet Therapy or No Therapy (Control), Non-Antithrombotic Therapy
- Where
- 21 sites in Japan
- Volunteers
- 500 people
- Sponsor
- OCEAN-SHD Study Group
Atrial Fibrillation, Device Related Thrombus
Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers.
- Conditions
- Atrial Fibrillation, Device Related Thrombus, Left Atrial Appendage Thrombosis, Watchman LAA Closure Device
- Trial name
- DEA-LAA (NCT03539055)
- Testing
- Dabigatran Etexilate Oral Capsule
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Vanderbilt University Medical Center
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
Left Atrial Appendage Closure
Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure. (SWISS-APERO)
Left atrial appendage closure (LAAC) is an emerging therapeutic option in non-valvular atrial fibrillation (NVAF) patients with high thromboembolic and bleeding risks.
- Trial name
- SWISS-APERO (NCT03399851)
- Testing
- Amplatzer Amulet for left atrial appendage closure, Watchman/FLX for left atrial appendage closure
- Where
- 8 sites in Belgium, France and 2 more
- Volunteers
- 200 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Left Atrial Appendage Closure, WATCHMAN Device Implantation
The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial
This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other bio-markers, will be measure before…
- Trial name
- NCT03040622
- Testing
- WATCHMAN Left Atrial Appendage Closure
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Inova Health Care Services
Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe
The ICE WATCHMAN Trial
The aim of this multi-center study will be to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol…
- Trial name
- NCT04569734
- Testing
- WATCHMAN device implant procedure utilizing ICE probe
- Where
- 2 sites in United States
- Volunteers
- 101 people
- Sponsor
- Mayo Clinic
Atrial Fibrillation, Left Atrial Appendage Closure
The Usefulness of Biatrial 3D Printing to Plan Transseptal Puncture for the Left Atrial Appendage Closure
The aim of the study is to assess the usefulness of pre-procedural 3D printing of both atria to plan optimum site for transseptal puncture for the left atrial appendage closure.
- Trial name
- NCT05743322
- Testing
- Left atrial appendage closure
- Where
- Czechia
- Volunteers
- 60 people
- Sponsor
- Charles University, Czech Republic