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
VOLT-AF IDE Clinical Study
This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™
Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT
Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Abl...
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
LS-PersAFone: Pulsed Field Ablation for Long-Standing Persistent Atrial Fibrillation
This is a prospective, single-arm trial. The objective of the study is to determine the rate of atrial arrhythmia recurrence after pulmonary vein isolation (PVI) plus posterior wall isolation (PWI) using the Farawave PFA catheter in patients with longstanding persistent...
Age: 18 years - 66+
Gender: All
Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
The primary objective of this clinical investigation is to demonstrate the safety and
12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation
in the treatment of subjects with symptomatic paroxysmal and persistent atrial
fibrillation ...
Age: 18 - 80 years
Gender: All
ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial. The purpose of the study is to determine the role of adjunctive renal sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients wit...
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
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...
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
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