View clinical trials related to Paroxysmal Atrial Fibrillation.
Filter by:Atrial fibrillation (AF) stands as the most common type of cardiac arrhythmia. The frequency of AF in the overall population is 1-2%, with the incidence rate increasing with age from 0.5% in the 40-50 years old to 5-15% in those aged 80. [According to current recommendations for catheter ablation (CA) in patients with AF, the isolation of the pulmonary veins (PV) is a pivotal aspect of treating this arrhythmia. Despite recent advancements, 20-45% of patients experience recurrences after PV isolation. According to the study by Wasmer K. et al., it was demonstrated that most patients with recurrent AF after PVI showed at least one reconnected vein during redo procedures. The primary cause of recurrences is the restoration of conduction, attributed to endurable isolation (non-transmural, intermittent RF). Numerous approaches have been presented to enhance the outcomes of surgical treatment for AF, such as the CLOSE protocol and Ablation Index (AI) . CLOSE protocol represents an approach aimed at isolating the PV ostia through precise continuous (distance between points ≤ 6 mm) radiofrequency intervention, achieving target ablation index values of ≥ 400au for the posterior wall and ≥ 500au for the anterior wall. The Ablation Index is a marker of quality lesion formation, providing a visual representation of the lesion based on the integration of power, contact force, and time parameters, which is displayed on the CARTO® 3 system (Biosense Webster). Throughout radiofrequency ablation, electromagnetic energy undergoes conversion into thermal energy, leading to tissue damage and temperature elevation. The temperature elevation process encompasses two stages: resistive heating, impacting surface tissues (1-2mm), and conductive heating, which facilitates the transfer of heat from surface tissues to underlying tissues. In the presence of good catheter-endocardium contact (25%), only 9% of the power is effectively delivered to the endocardium. For instance, at a power level of 30 watts and optimal contact (25%) with the endocardium, merely 2.7 watts are transferred to the endocardial tissue. When applying 30 watts of power for 30 seconds, a total energy delivery of 900 joules occurs, with only 90 joules being imparted to the endocardium. Similarly, at 50 watts for 10 seconds, only 45 joules of energy are transmitted to the endocardium. When operating at 10 watts, the catheter temperature elevates by 13°C. Consequently, at 30 watts, the temperature reaches 39°C, and at 50 watts, it rises to 65°C. The formation of an irreversible lesion necessitates a temperature exceeding 50°C. During standard radiofrequency ablation (RFA) procedures with power settings ranging from 20 to 45 watts and a duration of 20 to 60 seconds, the formation of ablation points predominantly occurs during the conductive heating phase. High power short duration ablation (HPSD) is an approach that reduces the conductive heating phase while increasing the resistive heating phase. This results in an expanded area of lesion, facilitating the formation of transmural lesions in the atrial myocardium with irreversible tissue damage and reduced risk to surrounding structures, such as thermal injury to the esophagus. The strategy of HPSD ablation was developed to overcome limitations of the traditional approach. However, much remains unknown regarding the safety and effectiveness of this approach. Additionally, the question for the optimal interventional treatment method for atrial fibrillation (AF) and the selection of the optimal RF energy for pulmonary vein isolation still require confirmation. This forms the basis for our research objective.
Background: quality of life is impaired in patients with paroxysmal atrial fibrillation. The purpose of this study is to explore the mediating effects of self-efficacy, coping, depression, and anxiety on the quality of life of patients with paroxysmal atrial fibrillation. Methods: It is a cross-sectional study trial. This study aims to enroll 100 patients with paroxysmal atrial fibrillation. Illness perceptions (Brief Illness Perceptions Questionnaire; BIPQ), coping styles (Carver Brief-COPE scale; B-COPE), depression Patient Health Questionnaire-9 ,PHQ-9),anxiety (The Generalized Anxiety Disorder Questionnaire, GAD 7) and quality of life (12-item Short Form Health Survey,SF12) will be analysed. This study intends to use correlation analysis and mediation analyses to assess the mediating effects of self-efficacy, coping, depression and anxiety on the quality of life of patients with paroxysmal atrial fibrillation.
The purpose of this study is to assess the performance and safety of using the investigational catheter.
High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: safety and acute procedural outcome
The goal of this retrospective registry is to evaluate the efficacy and safety of Refralon®, concentrate for solution for intravenous injection, as chemical cardioversion in patients with paroxysmal and persistent atrial fibrillation and flutter in routine clinical practice. The main questions it aims to answer are: - What is the incidence of sinus rhythm restoration within 6 hours in patients with paroxysmal atrial fibrillation (AF)/atrial flutter (AFL) after the first dose of Refralon®? - What is the incidence of sinus rhythm restoration within 24 hours in patients with persistent AF/AFL after the first dose of Refralon®?
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.
The purpose of this clinical trial is to evaluate the safety and efficacy of a pulsed field ablation system developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd in the treatment of patients with paroxysmal atrial fibrillation
A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.