Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System
This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping
and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly
assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Ca...
Age: 18 - 80 years
Gender: All
CHAMPION-AF Clinical Trial
The primary objective of this study is to determine if left atrial appendage closure (LAAC)
with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants
in patients with non-valvular atrial fibrillation.
Age: 18 years - 66+
Gender: All
CHAMPION-AF Clinical Trial
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.
Age: 18 years - 66+
Gender: All
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 long-term NOAC therapy.
The clinical in...
Age: 18 years - 66+
Gender: All
Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation
The purpose of the ULTRA-HFIB Pilot is to determine the role of adjunctive renal denervation
(RDN) in the prevention of Atrial Fibrillation (AF) recurrence in patients scheduled for an
AF ablation procedure. Patients will be randomized to either i) AF ablation (Cont...
Age: 18 years - 66+
Gender: All
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation
System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial
fibrillation (AF).
Age: 18 years - 66+
Gender: All
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
The primary objective of this study is to evaluate the effectiveness (prevention of
thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to
background antiplatelet therapy in patients who develop new-onset post-operative atrial
f...
Age: 18 years - 66+
Gender: All
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite
outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with
recent ICH and atrial fibrillation (AF).
Secondary Aim: To determine if apixaban...
Age: 18 years - 66+
Gender: All
AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment
The primary objective of this study is to evaluate the safety and effectiveness of the
AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with Left
Atrial Appendage (LAA) exclusion using the AtriClip device.
Age: 18 years - 66+
Gender: All
DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the
DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent
atrial fibrillation in patients.
Age: 18 years - 66+
Gender: All
DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the
DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent
atrial fibrillation in patients.
Age: 18 years - 66+
Gender: All
The CONFORMAL Early Feasibility Study
An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion
Age: 18 years - 66+
Gender: All
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
This clinical investigation is intended to demonstrate the acute safety and effectiveness of
ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)
for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibri...
Age: 18 years - 66+
Gender: All
Model Based Fast Anatomical Mapping
This prospective, multicenter observational study will examine the ability of model based
fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation
ablation.
Age: 18 years - 66+
Gender: All
Model Based Fast Anatomical Mapping
This prospective, multicenter observational study will examine the ability of model based
fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation
ablation.
Age: 18 years - 66+
Gender: All
CardioFocus HeartLight Post-Approval Study
This is a post-approval study to evaluate the clinical outcomes in a cohort of participants
treated during commercial use of the HeartLight System to confirm results of the previously
conducted pivotal clinical study.
Age: 18 years - 66+
Gender: All
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible...
Age: 18 years - 66+
Gender: All
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Patients without a documented history of AF but who present with a CHA2DS2- VASc of => 2 and HASBLED of => 2 and will undergo a valve or CABG (structural heart) procedure with direct visual access to the LAA will be eligible to participate based upon the inclusion...
Age: 18 years - 66+
Gender: All
Feasibility Study of a Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation
The purpose of this study is to assess the safety and function of the Aegis Sierra Ligation
System in accessing and closing off the left atrial appendage (LAA) using a minimally
invasive epicardial access approach.
A minimum of 30 participants will be included in thi...
Age: 18 years - 66+
Gender: All