Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.
Age: 18 - 80 years
Gender: All
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
The purpose of this study is to establish the safety of the pulsed field ablation (PFA)
therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of
atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its
non-inferiority ...
Age: 18 years - 66+
Gender: All
Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias
The purpose of this pragmatic study is to evaluate the safety, performance and
effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination
with the FARASTAR generator), to treat patients with atrial fibrillation during
clinically-indicated a...
Age: 18 years - 66+
Gender: All
SIMPLAAFY Clinical Trial
The primary objective is to demonstrate the safety and effectiveness of two monotherapy
regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN
FLX Pro device in a commercial clinical setting.
Age: 18 years - 66+
Gender: All
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the
BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in
the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an
...
Age: 18 - 80 years
Gender: All
Laminar LAAX Pivotal IDE Study
The goal of this clinical trial is to compare the Laminar Left Atrial Appendage Closure
System to commercially available left atrial appendage closure devices. This procedure is
for patients with non-valvular atrial fibrillation who are at increased risk for stroke,
...
Age: 18 years - 66+
Gender: All
Laminar LAAX Pivotal IDE Study
The goal of this clinical trial is to compare the Laminar Left Atrial Appendage Closure
System to commercially available left atrial appendage closure devices. This procedure is
for patients with non-valvular atrial fibrillation who are at increased risk for stroke,
...
Age: 18 years - 66+
Gender: All
RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.
Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap®
System in patients with all types of atrial fibrillation (AF) including paroxysmal or
persistent or long-standing persistent, undergoing and De Novo or Redo procedures.
Pheno...
Age: 18 - 80 years
Gender: All
The CONFORM Pivotal Trial
The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patient...
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 inves...
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, c...
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
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