View clinical trials related to Paroxysmal Atrial Fibrillation.
Filter by:Atrial The treatment of atrial fibrillation (AF) includes 2 axes: the prevention of the cardio-embolic risk and rhythm control. The possibilities for this control are antiarrhythmic drugs and, above all, catheter ablation, an interventional cardiology technique which consists in treating the areas responsible for the initiation and perpetuation of AF by applying radiofrequency energy or cryotherapy to the myocardial tissue. Limited research has been done on the combination of different parameters to manage AF, especially during the initial stage of the disease. A translational and multimodal approach could make it possible to better characterize this pathology and thus, help to adjust the therapeutic management for the patients. The combined analysis of regional electrophysiological, morphological, and functional parameters of the left atrium could make it possible to better detect early atrial cardiomyopathy and predict recurrences of atrial fibrillation.
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Currently, Medtronic Arctic Front Cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming technologies. A novel method, pulse-field ablation (PFA) using the FARAPULSE catheter, has recently been introduced (FARAPULSE PFA, Boston Scientific). However, whether FARAPULSE PFA provides effectiveness similar to the standard-of-practice Medtronic Arctic Front Cryoballoon is yet to be investigated. Given that FARAPULSE PFA has shown in studies not to cause any of the severe complications reported in association with traditional PVI while being highly effective, it might be even safer and more effective for use in AF ablation procedures. The aim of this trial is to compare the efficacy and safety of PVI using FARAPULSE PFA (Boston Scientific) and the Arctic Front Cryoballoon (Medtronic) in patients with symptomatic paroxysmal AF undergoing their first PVI. This is an investigator-initiated, multicenter, randomized controlled, open-label trial with blinded endpoint adjudication. Given that the Medtronic Arctic Front Cryoballoon is the standard-of-practice for PVI and the FARAPULSE PFA is the novel technology, this trial has a non-inferiority design. The null hypothesis with regards to the primary efficacy endpoint is that the FARAPULSE PFA (Boston Scientific) shows lower efficacy compared to the Arctic Front Cryoballoon (Medtronic) and that therefore more episodes of first recurrence of any atrial arrhythmia between days 91 and 365 will be observed in patients with symptomatic paroxysmal AF undergoing their first PVI. Hence, the alternative hypothesis postulates that the FARAPULSE PFA is non-inferior to the Arctic Front Cryoballoon. Rejection of the null hypothesis is needed to conclude non-inferiority.
The real world study is a retrospective and/or prospective, single-center, single-arm observational study to observe the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System for treatment of recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) in a Chinese population.
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).
This study is aimed to evaluate the Efficacy and Safety of Pulsed Field Ablation (PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF)
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
Cryoballoon ablation has emerged as a safe and effective strategy for treatment of atrial fibrillation (AF) for which it has recently received a 'first-line' therapy indication by the FDA. Pulmonary vein (PV) isolation (PVI) has been the cornerstone of this procedure achieving freedom from recurrent AF in up to ~80% of patients at 12 months of follow-up. However, the success has been shown to be significantly lower, in the range of 50-60% at 3-5 years of follow-up. Other more recent cryoballoon ablation studies have demonstrated marked improvements in clinical outcomes associated with concomitant PVI and cryoballoon ablation/isolation of the 'PV component' (a region of the left atrial posterior [back] wall lying between the PVs that is anatomically and embryologically related to the PVs), versus PVI alone in patients with persistent AF. PVI+PWI using cryoballoon ablation has been widely-practiced in patients with paroxysmal AF. However, the acute/long-term safety and efficacy of this approach has not been formally investigated in paroxysmal AF. Given the mechanistic similarities between persistent and paroxysmal AF, we hypothesize that similar benefits associated with PVI+PWI may also be observed in those with paroxysmal AF. Yet, due to the relative infrequency of breakthrough/recurrent arrhythmias in patients with PAF, to detect a significant difference, large sample sizes and extended follow-up (>24 months) are likely needed. Hence, the aim of this retrospective, observational study is to examine the acute and long-term efficacy and safety beyond 36 months of follow-up associated with PVI alone versus PVI+PWI using cryoballoon ablation in a large cohort of patients with PAF, performed by a single operator (A. Aryana) between 1/1/2014 and 8/31/2018 at Mercy General Hospital.
AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish the clinical performance of the AFib-Chek device (a.k.a. Device) on human participants.
This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)