View clinical trials related to Paroxysmal Atrial Fibrillation.
Filter by:Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).
Pulmonary vein isolation using cryoballoon ablation is well established method for the treatment of atrial fibrillation. As a rule, cryoenergy delivery is preceded by documenting the full vein occlusion. It is assessed by venography, performed by injecting contrast through the inner lumen of the balloon catheter after the vein is blocked with a balloon. Achieving full vein occlusion in certain situations can be challenging and may require multiple attempts, which may expose the patient to increased doses of contrast and radiation.. At the same time, the purpose of ablation is an electrical isolation of pulmonary veins. Experts postulate ablation in the antrum and the so-called "proximal-seal technique", which in some cases may require to start cryoapplication before the vein is fully sealed. This approach minimizes the risk of the pulmonary vein stenosis, damage to structures immediately adjacent to the atrium and phrenic nerve palsy. In addition, in many cases the displacement of the balloon after several dozen seconds of cryoapplication, usually by pulling it, causes full sealing of the vein, contributes to further lowering the temperature and leads to full electrical isolation of the vein, which is the aims of ablation. All the above-mentioned facts indicate that demonstrating full vein occlusion using angiography before the initiation of cryoenergy application is of limited value. Moreover, there are a number of parameters related to cryoballoon ablation that indicate acute and long term vein isolation. Taking into account the arguments presented above, it seems that it is possible to perform an effective and safe isolation of the pulmonary veins using the cryoballoon ablation technique without confirmation by venography that PV is occluded. Along with dissemination of the method, such attempts are and will be made by some operators. Therefore, a systematic approach to this issue is important. It should define the conditions that should be met in order for the procedure in the proposed modification to be implemented effectively and safely. In addition, a protocol of ablation for this modification is required.
Current international guidelines recommend a three-month blanking period after pulmonary vein isolation (PVI) for atrial fibrillation (AF). Early recurrence of atrial tachyarrhythmia (ERAT; comprising of AF, left atrial tachycardia and atrial flutter) is common, occurring in up to 65% of patients, but in the first month is generally thought not to predict long-term AF recurrence, and re-intervention is not recommended. Suggested causes for ERAT include inflammation and arrhythmogenic structural changes caused by ablation lesions. Early, purely inflammatory ERAT would not lead to late AF recurrence as pulmonary vein reconnection is established as the main factor associated with long-term recurrence in paroxysmal AF. Previous studies have shown ERAT in the second to third month (rather than first month) to be a stronger predictor of late AF recurrence, due to presumed reduction in the contribution of the acute inflammatory response after this. Biochemical data have shown that the post-ablation inflammatory phase is usually limited to the first month after both radiofrequency (RF) and cryoballoon (CB) ablation, though inflammatory markers have been shown to be less elevated following CB PVI. Histologically, lesions formed by the two modalities differ significantly. RF lesions are characterised by irregular boundaries and significant disruption to the endothelium, exposing the sub-endothelial layer and resulting in significant and sustained platelet activation, changes which can last for many months. CB lesions on the other hand, are observed as well demarcated and homogenous within one week, with reduced thrombogenicity, which may lead to reduced inflammation. ERAT following CB ablation cannot be accurately predicted by inflammatory response and it is postulated that endothelial function may play a role in the development of ERAT in such patients. Some studies have shown reduced recurrence rate and re-hospitalisation amongst the CB population, including the FIRE and ICE trial, potentially resulting in a better patient experience with CB and the possibility of a shorter blanking period. Post-ablation inflammatory response is more predictive of ERAT following RF than CB PVI, and the latter is considered to be associated with less inflammation. There is however, a paucity of data evaluating endothelial function post-AF ablation and its correlation with ERAT or late recurrences of arrhythmia. Given that earlier re-intervention in patients with ERAT in the third month of the blanking period can result in greater outcomes with respect to late recurrence of AF, if it can be demonstrated that endothelial function testing in the first few months post-CB PVI can be predictive of later ERAT, then shortening the blanking period following CB PVI and performing repeat ablation to control troublesome later ERAT may reduce overall patient morbidity and re-hospitalisation. The purpose of this novel pilot study is to examine the relationship between the post-ablation inflammatory response, endothelial function and timing and frequency of ERAT for patients undergoing RF and CB PVI for paroxysmal or short-lived persistent (less than 6 months' duration) AF. If the initial data provides hypothesis generating information, the aim would be to perform the study on a larger basis with higher statistical power to determine whether early post-ablation endothelial function testing can predict recurrences and identify those suitable for earlier re-intervention.
PEFCAT II: Expanded Safety and Feasibility Study of the FARAPULSE Endocardial Multi Ablation System to Treat 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).
Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation In Paroxysmal AF Patients Using Cryoballoon
The primary purpose of this registry is to obtain real-world clinical experience of Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation ablation radiofrequency (RF) technologies. Data from the registry will be used to assess clinical outcomes, including procedural efficiency, safety, and long-term, effectiveness of catheter ablation with novel RF technologies in PAF and PsAF patients.
Atrial fibrillation (AF) is one of the most common heart rhythm disorders and it is associated with a variety of symptoms leading to a considerable deterioration in quality of life. The Mental-AF trial is intended to inquire if an app-based mental training can reduce the occurrence of symptomatic AF episodes within the blanking period, i.e. the first three months after catheter ablation for AF.
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.
A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI). Prospectively or retrospectively record 150 eligible subjects since 1st Jan 2019 to evaluate effectiveness and safety of STSF with AI.