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This is a prospective, pilot study using the Attune Medical esophageal heat transfer device to rapidly cool the esophagus during RF ablation procedures. According to the Instructions for Use, once the patient is intubated, the esophageal heat transfer device will be introduced into the esophagus. When the esophageal heat transfer device has reached a temperature of 4-6 degrees C for at least 2 minutes, Posterior left atrial wall ablation using standard parameters will only be performed.
Source link: https://clinicaltrials.gov/ct2/show/NCT04063761
Sudden cardiac death due to recurrent ventricular tachycardia is a significant medical manifestation in patients with structural heart disease. Scar tissue formations arise as a result of an ischemic cardiomyopathy (previous coronary disease) or a non-ischemic cardiomyopathy associated with an infectious or genetic disorder. This information shows a substantial benefit of CA over medical therapy in terms of VT-free survival, surviving without VT storm, and VT burden. CA is proven to be safe in preventing VT in NICM patients who have failed AADs, resulting in a decrease in VT burden and AAD use over a long-term follow-up. In addition, there is no evidence pointing to the correct-world scenario of patients with structural heart disease presenting with VT in early ICM with VT or advanced ICM with VT.
Source link: https://clinicaltrials.gov/ct2/show/NCT05524077
Subjects undergoing the first ablation procedure for PAF have no prior left atrial ablation, according to De Novo PAF. The study will include the following Boston Scientific Open-Irrigated Catheters in geographies where commercially approved for PAF ablation: IntellaNav Intui Catheter IntellaNav is the most advanced version of the IntellaNav product line: IntellaNav Open-Irrigated Catheter In the study: The following Blown-Irrigated Ablation Catheter IntellaNav MiFi Open-Irrigated Catheter In the following Rhythmi /The study will include the following: IntellaCheter Rhythmirrigated Catheter Intella heter Ti. . The Philadelphia scientific Open-Irrigated Catheters' enrollment requirements, signing the agreement, and undergoing the index procedure with the study devices will be followed for three years by the FDA to obtain post-market data for Boston Scientific Open-Irrigated Catheters, which will be followed for three years.
Source link: https://clinicaltrials.gov/ct2/show/NCT03729830
One of the most significant challenges faced by physicians is the issue of PV reconnection and recurrent AF after catheter ablation of paroxysmal AF. Rationale: The recognition of the role of contact force during catheter ablation, as well as the fact that it may reduce pulmonary vein reconnection and AF recurrence is a significant step forward in catheter ablation for AF. A few small clinical trials have shown the efficiency and afability of contact force guided catheter ablation in lowering PV reconnection and AF recurrence. The investigators have devised a novel "augmented" CF-led ablation scheme and will try this against the current gold standard ablation technique. Our aim is to investigate an augmented-wide circumferential catheter ablation scheme (with the possibility of pulmonary vein reconnection and AF recurrence in patients with paroxysmal AF, using contact force technology. Hypothesis: An improved-wide area circumferential catheter ablation program in patients with symptomatic paroxysmal AF will result in fewer electrocardiographically documented atrial arrhythmias recurrences in patients with conventional wide-area catheter ablation. Both four pulmonary veins will be circumferential catheter ablation around all four pulmonary veins until the point of electrical isolation. After completion of the lesion set, adenosine will be tested, and additional lesions will be introduced to remove dormant PV conduction.
Source link: https://clinicaltrials.gov/ct2/show/NCT02150902
This research was designed to investigate the effects of the pressure change on clinical outcomes by measuring the left and right atrial pressure change before and after catheterization and left atrial appendage closure (combative procedure). i. Atrial fibrillation observed by 12-lead ECG or Holter that lasted for longer than 30 seconds within the preceding 6 months; i. At risk of stroke and/or bleeding, those who have at least one of the following conditions are eligible for left atrial appendage closure; Contraindicated to oral anticoagulation; Refused OAC therapy, although fully informed of the importance and benefits of OAC therapy. The energy source for CA is optional, but for CA, it is optional. Only for pulmonary vein isolation, ablation should be done. The right atrial pressure should be measured before transseptal puncture and after combined procedure is carried out for atrial pressure measurement. Left atrial pressure should be measured at three timepoints: after transseptal puncture, after pulmonary vein isolation, and after LAAC. endpoints include a primary composite endpoint of rehospitalization due to heart disease and death due to cardiovascular disease, as well as secondary endpoints including: 1. all-cause mortality 2. evaluation of left atrial appendage closure 9. The anti-thromboembolic therapy should follow, with 3-month OAC diagnosis and three-month double anti-platelet therapy and lifelong single anti-platelet therapy.
Source link: https://clinicaltrials.gov/ct2/show/NCT05106270
The most common supraventricular tachycardia inducible during an electrophysiological investigation is Atrioventricular nodal reentrant tachycardia. The aim of this investigation is to determine the presence and configuration of specific electrograms representing slow pathway possibilities as well as Koch's triangle pattern activation during sinus rhythm and/or atrial extraestimulus with a high-density mapping catheter in an effort to determine a fast and safety catheter ablation procedure. When doing a new 3D HDM, SP signals should eventually fade after the RF procedure. Patients without an AVN dual physiology should show the absence of fragmented/slow conduction zones.
Source link: https://clinicaltrials.gov/ct2/show/NCT05531903
Ventricular tachycardia is a common, rapid heart rhythm resulting from intermittent electrical conduction in the ventricles of the heart. The overwhelming number of VT cases are due to Coronary heart disease. Electrophysiologic mapping can be used to localize the arrhythmogenic focus, which can be later confirmed with cardiac catheter radiofrequency ablation. Many patients are still experiencing episodes of VT refractory to both medications and multiple catheter ablation attempts. Stereotactic body radiotherapy is a treatment used most commonly as a cancer cure, in which a targeted, high dose of radiation is delivered to a target. Noninvasive targeting of the arrhythmogenic substrate with SBRT is an emerging method with promising results. For patients with VT refractory to medication and catheter ablation, noninvasive targeting of the arrhythmogenic substrate with SBRT is a new approach with promising results.
Source link: https://clinicaltrials.gov/ct2/show/NCT04757688
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