Clinical trials: Atrial Appendage, open to volunteers
Mitral Stenosis
Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis.
Evaluation of the effect of PTMC on LAA function by TEE at least one month after the procedure and its effectiveness in prevention of thrombi formation and cerebrovascular complications.
- Trial name
- NCT06340997
- Testing
- Transesophageal echocardiography
- Volunteers
- 25 people
- Sponsor
- Assiut University
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
Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
The purpose of the project is to elucidate whether it is possible to identify which patients are at risk of forming blood clots that can cause stroke based on analysis of the electrocardiogram.
- Trial name
- LAATAS (NCT06405750)
- Testing
- left atrial appendage closure
- Where
- Denmark
- Volunteers
- 1,000 people
- Sponsor
- University Hospital Bispebjerg and Frederiksberg
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
Ischemic Stroke, Atrial Fibrillation
Single-stage Pulmonary Vein Isolation Combined With Percutaneous Left Atrial Appendage Occluder Implantation in Patients With Recent Onset Ischemic Stroke and Atrial Fibrillation
The project is a multicenter, open-label, randomized medical experiment, which was designed to evaluate the efficacy and safety of single-stage pulmonary vein isolation (PVI) and implantation of left atrial appendage occluder…
- Trial name
- PILOS-AF (NCT06212674)
- Testing
- PVI + LAAO, single stage, LAAO, NOAC
- Where
- 2 sites in Poland
- Volunteers
- 240 people
- Sponsor
- Medical University of Silesia
Ischemic Heart Disease, Ischemic Cardiomyopathy
Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery
Ischemic heart disease (IHD) leads the global mortality statistics. Atherosclerotic plaques in coronary arteries hallmark IHD, drive hypoxia, and may rupture to result in myocardial infarction (MI) and death of contractile…
- Conditions
- Ischemic Heart Disease, Ischemic Cardiomyopathy, Heart Failure, Systolic, Heart Failure NYHA Class III
- Trial name
- AAMS2 (NCT05632432)
- Testing
- Epicardial AAMs-patch transplantation, RNA-stabilized whole blood sampling, Plasma sampling
- Where
- Finland
- Volunteers
- 50 people
- Sponsor
- Hospital District of Helsinki and Uusimaa
Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation
EPX-HTG for Structural Heart Procedures
To investigate and evaluate the benefits of adding EchoPixel Holographic Therapy Guidance to the current standard of care in Structural Heart (SH) procedures.
- Trial name
- EPX-HTG-2026 (NCT07705425)
- Testing
- Left Atrial Appendage Occlusion, Mitral Valve Transcatheter Edge to Edge Repair
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- EchoPixel, Inc.
Atrial Fibrillation
MANAGE-AF Registry -MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
The purpose of this research is to learn more about the normal care of patients with a new or pre-existing diagnosis of atrial fibrillation (AF).
- Trial name
- MANAGE-AF (NCT05978466)
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- CorVita Science Foundation
Device Related Thrombosis, Peri-device Leak
Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance.
- Trial name
- NCT06523166
- Testing
- Transesophageal echocardiography (TEE), Cardiac CTA
- Where
- 5 sites in United States
- Volunteers
- 320 people
- Sponsor
- University Hospitals Cleveland Medical Center
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
Heart Failure, Atrial Fibrillation (AF)
Bachmann Bundle Pacing for Prevention of New-Onset Atrial Fibrillation in Patients With Heart Failure
This is a multi-center, prospective, single-blind, randomized controlled clinical trial to evaluate the efficacy and safety of Bachmann bundle pacing (BBP) in preventing new-onset atrial fibrillation (AF) in patients with chronic…
- Conditions
- Heart Failure, Atrial Fibrillation (AF), Cardiac Insufficiency
- Trial name
- NCT07547449
- Testing
- Bachmann Bundle Pacing, Right Atrial Appendage Pacing
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fu Wai Hospital, Beijing, China
Non Valvular Atrial Fibrillation
Applause Study I - Append System Early Feasibility Study
This early feasibility study is intended to evaluate the safety and feasibility of the Append System for eliminating the left atrial appendage (LAA) through a transcatheter procedure that invaginates and ligates the LAA tissue.
- Trial name
- Applause (NCT07278869)
- Testing
- Left Atrial Appendage Elimination: Append System
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Append Medical Ltd.
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 (AF)
Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for…
- Trial name
- PRECLUDE (NCT07620262)
- Testing
- Remapping Procedure
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Northwell Health