Clinical trials: Left Atrial Appendage Exclusion
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
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.
Atrial Fibrillation, Persistent
Subxyphoid Hybrid MAZE Registry for Patients With Persistent Atrial Fibrillation
Minimally invasive surgical procedures have been advocated as an alternative to catheter ablation for the treatment of persistent atrial fibrillation.
- Trial name
- SubXMAZE (NCT04148625)
- Volunteers
- 100 people
- Sponsor
- University of California, San Francisco
Left Atrial Appendage Exclusion
AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.
- Trial name
- EXCLUDE (NCT00779857)
- Testing
- AtriCure LAA Exclusion System
- Where
- 7 sites in United States
- Volunteers
- 70 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation, Thromboembolism
Impact of Left Atrial Appendage Exclusion on Short-Term Clinical Outcomes and Long-Term Stroke Incidence
Stroke is a major cause of morbidity in western society, and an infrequent complication of cardiac surgery. The majority of thromboembolic strokes arise from the left atrium, in particular the left atrial appendage.
- Conditions
- Atrial Fibrillation, Thromboembolism, Cerebrovascular Accident
- Trial name
- NCT00486915
- Testing
- Left Atrial Appendage Ligation
- Where
- Italy
- Volunteers
- 43 people
- Sponsor
- London Health Sciences Centre
Atrial Appendage
Left Atrial Appendage Exclusion Study
Evaluate the safety and effectiveness of the LARIAT Suture Delivery device in excluding the left atrial appendage in 100 patients.
- Trial name
- PLACE II (NCT01983605)
- Testing
- LARIAT Suture Delivery Device
- Where
- Poland
- Volunteers
- 96 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III
This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or…
- Trial name
- PLACE III (NCT01680757)
- Testing
- LARIAT Suture Delivery Device and Accessories
- Where
- 12 sites in United States, Germany and 1 more
- Sponsor
- University of California, San Francisco
Post Operative Atrial Fibrillation, Atrial Fibrillation, Postoperative
BoxX-NoAF Clinical Trial
Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics and surgery type.
- Trial name
- NCT06989775
- Testing
- Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System
- Where
- 37 sites in United States, Canada
- Volunteers
- 960 people, healthy volunteers welcome
- Sponsor
- AtriCure, Inc.
Ischemic Stroke, Systemic Embolism
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of…
- Trial name
- LeAAPS (NCT05478304)
- Testing
- AtriClip LAA Exclusion System
- Where
- 138 sites in United States, Australia and 8 more
- Volunteers
- 6,573 people
- Sponsor
- AtriCure, Inc.
Stroke
Exclusion of the Left Atrial Appendage (LAA) With the LAAx, Inc. TigerPaw System
The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual…
- Trial name
- NCT00962702
- Testing
- LAAx TigerPaw System
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- LAAx, Inc.
Atrial Fibrillation, AFib
Stroke Feasibility Study
This is a feasibility study to assess the safety and efficacy of the AtriCure AtriClip when placed via Minimally Invasive Surgical Deployment to the Left Atrial Appendage.
- Trial name
- NCT01997905
- Testing
- AtriClip LAA Exclusion Device
- Where
- 7 sites in United States
- Volunteers
- 13 people
- Sponsor
- AtriCure, Inc.
Heart Diseases
Video-Assisted Left Atrial Appendage Exclusion Trial
Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique is safe and effective.
- Trial name
- VALET (NCT02226133)
- Testing
- LAAx, Inc. TigerPaw® System II
- Where
- 4 sites in United States
- Sponsor
- LAAx, Inc.
Atrial Fibrillation
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB
Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left…
- Trial name
- RESTORE SR IIB (NCT00571779)
- Testing
- AtriCure Bipolar System
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Sole-Therapy Treatment of Atrial Fibrillation
RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not…
- Trial name
- RESTORE SR II (NCT00566176)
- Testing
- Surgical Ablation using the AtriCure Bipolar System
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation (AF), Pulmonary Embolism (PE)
Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study
This study aims to investigate whether a quick, additional CT scan of the heart, performed immediately after a standard CT scan for pulmonary embolism, can effectively detect blood clots in the left atrial appendage (LAA) in…
- Conditions
- Atrial Fibrillation (AF), Pulmonary Embolism (PE), Left Atrial Appendage Thrombosis
- Trial name
- ELATE-AF (NCT07647939)
- Testing
- Delayed Un-gated CT Scan for Left Atrial Appendage Thrombus, Delayed Gated CT Scan for Left Atrial Appendage Thrombus
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Northwell Health
Atrial Fibrillation
Multidetector CT Left Appendage Atrial Thrombosis Exclusion in Patients With Atrial Fibrillation
The aim of the LATE (multidetector CT Lefi Appendage atrial Thrombosis Exclusion in patients with atrial fibrillation) study is to evaluate the diagnostic accuracy of cardiac Computed Tomography (TC) with 64 detectors and double…
- Trial name
- NCT06169332
- Volunteers
- 260 people
- Sponsor
- IRCCS San Raffaele
Atrial Appendage
CLAARITY is a Prospective, Observational, Single-arm, Multi-center, Post-market US Study Designed to Evaluate the Safety and Performance of the ECLIPTIS Left Atrial Appendage Exclusion System for Exclusion of the Left Atrial Appendage (LAA) During Concomitant Open-heart Cardiac Surgery.
CLAARITY is a prospective, observational, single-arm, multi-center, post-market US study designed to evaluate the safety and performance of the ECLIPTIS clip in a minimum of 168 participants.
- Trial name
- CLAARITY (NCT07742839)
- Testing
- Edwards ECLIPTIS Left Atrial Appendage Exclusion System
- Volunteers
- 168 people
- Sponsor
- Edwards Lifesciences
Post-Operative Atrial Fibrillation
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Patients without a documented history of Atrial Fibrillation (AF) and will undergo a valve or Coronary Artery Bypass Graft (CABG) procedure with direct visual access to the Left Atrial Appendage (LAA) will be eligible to…
- Trial name
- ATLAS (NCT02701062)
- Testing
- AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems, Anticoagulation Therapy
- Where
- 22 sites in United States
- Volunteers
- 562 people
- Sponsor
- AtriCure, Inc.