Arrhythmia

Researchers are evaluating two different pacing methods for patients with slow heart rates in this multi-center trial. The study compares the standard right ventricular pacing with a newer physiological pacing approach, which includes His bundle pacing or left bundle pacing. This trial aims to better understand the effects of these pacing methods on heart function and patient outcomes over time, including a sub-study focused on heart muscle changes related to pacing. Participants will receive a pacemaker implanted at a participating center and be randomly assigned to either right ventricular pacing or physiological pacing. For physiological pacing, if His or left bundle pacing is not successful, biventricular pacing will be used instead. The trial includes an optional echocardiographic sub-study for some patients to assess heart changes over 24 months. Participants will be followed for up to 78 months, with assessments at baseline and every six months. Researchers will measure outcomes such as survival, heart failure events, quality of life questionnaires, symptoms, device-related safety events, and heart rhythm data collected from the pacemakers. The sub-study will use echocardiograms to evaluate changes in heart volume and pumping efficiency. This comprehensive follow-up aims to capture both clinical effects and mechanistic insights of the pacing methods.

Researchers are exploring the link between myocardial fibrosis and outcomes in patients with Atrial Fibrillation (AF) after catheter ablation. The study focuses on using Cardiac CT to measure left ventricular extracellular volume (ECV) as a sign of fibrosis. It aims to see if higher ECV levels are connected to greater risks of AF returning, hospitalizations, and poor heart function recovery. This could help guide AF treatment decisions. Participants who are referred for catheter ablation will undergo an extra CT scan to measure ECV before the procedure. This is done during the standard pre-ablation cardiac CT that maps heart anatomy. The study uses a 320-detector CT to quantify ECV, a widely available and high-resolution method compared to MRI. The research assesses if ECV expansion relates to AF burden. During the study, outcomes such as AF recurrence and cardiovascular-related emergency visits or hospitalizations will be tracked for up to 90 days after the procedure. Heart function changes will be measured by ejection fraction, and quality of life will be assessed using the Atrial Fibrillation Effect on Quality-of-Life questionnaire. Participants will be monitored carefully during this period to evaluate these clinical outcomes.

Researchers are evaluating the potential benefits of implanting an implantable cardioverter defibrillator (ICD) in patients with coronary artery disease who have survived cardiac arrest caused by ventricular fibrillation or sustained ventricular tachycardia. These patients have undergone complete revascularization and have a left ventricular ejection fraction (LVEF) above 35%. The study aims to assess whether ICD implantation can improve survival outcomes compared to standard medical therapy. Participants are randomly assigned to one of two groups: one group receives an ICD implanted either during admission or within 4 weeks after discharge from the initial cardiac event, while the other group receives guideline-directed medical therapy without ICD implantation. The study compares these approaches to understand the effect of ICDs on survival in this patient population. During the study, participants will be monitored for outcomes including all-cause mortality over a five-year period, as well as mortality related to cardiovascular causes at one year. Researchers will collect data on sudden cardiovascular death and cardiovascular death within the first year. The trial includes follow-up assessments to track these outcomes and the overall health of participants throughout the study duration.

Researchers are evaluating the safety and feasibility of a new paddle-shaped, high-density, multi-electrode mapping catheter designed to map the atrial and ventricular regions of the heart. This study focuses on patients undergoing catheter mapping and ablation procedures to manage various cardiac arrhythmias, including atrial fibrillation, atrial tachycardia, ventricular tachycardia, and premature ventricular contractions. The trial is sponsored by Biosense Webster, Inc. and aims to monitor serious and non-serious adverse events related to the investigational catheter. Participants scheduled for a clinically indicated catheter mapping and ablation procedure will have the procedure performed using the investigational mapping catheter. The catheter is designed to provide detailed mapping of heart arrhythmias to guide the ablation therapy. The study period includes the index procedure and up to seven days of follow-up to assess safety and procedural success. Physicians may use the catheter for endocardial and, if indicated, epicardial mapping during the procedure. During the study, participants will undergo the catheter mapping and ablation procedure, and researchers will evaluate the catheter's deployment, visualization, maneuverability, and signal quality. Safety is monitored by recording any serious or non-serious adverse events within seven days after the procedure. Participants must comply with all pre-, post-, and follow-up testing and requirements, with the total relevant monitoring lasting up to seven days post-procedure.

Researchers are studying the long-term safety and effectiveness of the FDA-approved VARIPULSE catheter system used for pulmonary vein isolation (PVI) in people with symptomatic paroxysmal atrial fibrillation (PAF). This trial aims to evaluate how well this device manages treatment for this heart rhythm condition over an extended period. Participants who have symptomatic paroxysmal atrial fibrillation and are undergoing electrophysiology mapping and pulsed field ablation (PFA) will receive pulmonary vein ablation using the VARIPULSE catheter paired with a TRUPULSE generator. This treatment is designed to manage their atrial fibrillation symptoms by targeting specific areas of the heart. During the study, participants will be monitored for early onset primary adverse events within seven days after the ablation procedure. Researchers will also track freedom from both symptomatic and asymptomatic atrial tachyarrhythmia episodes from day 61 up to nearly three years after the procedure. Participants must comply with all pre-treatment, post-treatment, and follow-up testing and requirements throughout the study, which extends over a long-term period.

Researchers are evaluating the safety and effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) system for treating people with symptomatic paroxysmal atrial fibrillation (PAF), a condition causing irregular heart rates and abnormal blood flow. This study aims to assess the safety and 12-month effectiveness of this treatment approach in managing PAF symptoms. Participants will receive a pulsed field ablation procedure using the OMNYPULSE™ catheter combined with the TRUPULSE™ generator to isolate pulmonary veins and deliver pulsed field energy to treat atrial fibrillation. After the procedure, participants will be followed for 12 months to monitor outcomes related to the treatment. During the study, participants will undergo assessments to measure adverse events within 7 days after the procedure and track freedom from atrial tachyarrhythmia episodes between day 91 and day 365. Researchers will also evaluate changes in quality of life related to atrial fibrillation from the start of the study through 12 months. Participants will be monitored throughout the follow-up period to gather safety and effectiveness data.

Researchers are evaluating whether a nerve block procedure called stellate ganglion block can reduce the chance of atrial fibrillation after heart surgery. Atrial fibrillation is an abnormal, fast heartbeat in the upper chambers of the heart. The study aims to see if blocking the stellate ganglion with a local anesthetic before surgery can lower how often and how long atrial fibrillation occurs after the operation. Participants are randomly assigned to receive either a single injection of bupivacaine, a local anesthetic, or a saline placebo into the stellate ganglion on the right side of the neck before cardiac surgery. This procedure is guided by ultrasound and done in a sterile manner. The study compares the effects of the anesthetic versus placebo on the incidence and duration of atrial fibrillation within one week after surgery or during the hospital stay if discharged earlier. During the study, researchers will monitor the occurrence and length of atrial fibrillation after surgery. They will also assess the success of the nerve block by measuring changes in hand temperature and skin sympathetic nerve activity shortly after the procedure. Participants will be followed for up to one week post-surgery or until hospital discharge, with close observation to collect these measurements and evaluate any effects of the nerve block.

Researchers are evaluating the use and workflow of the pulsed field (PF) ablation system, including the VARIPULSE catheter, TRUPULSE generator, and new VARIPULSE Pro software, in participants with paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PsAF). These heart rhythm disorders involve irregular heartbeats of varying durations, and the study aims to better understand the clinical use of this device setup for cardiac ablation. The study is interventional and sponsored by Biosense Webster, Inc. Participants will undergo cardiac ablation using the pulsed field ablation system with the VARIPULSE catheter and TRUPULSE generator combined with the VARIPULSE Pro software. This procedure targets pulmonary vein isolation (PVI) and may include cavotricuspid isthmus (CTI) dependent atrial flutter ablation. The study focuses on the ablation procedure workflow and device application during the treatment of symptomatic PAF or PsAF. Throughout the study, researchers will measure outcomes such as total procedure time, pulsed field application time, number of applications at different heart locations, pulmonary vein isolation time, fluoroscopy time, catheter dwell time, and acute effectiveness during the procedure. Safety outcomes include monitoring for serious and non-serious adverse device effects up to three months after the procedure. Participants will need to comply with all pre-, post-, and follow-up assessments, including testing and clinical evaluations, during the study period.

Researchers are evaluating the clinical workflow of a pulsed field ablation system using the VARIPULSE catheter, TRUPULSE generator, and new VARIPULSE Pro software for treating participants with persistent atrial fibrillation (PsAF), a condition characterized by irregular, rapid heart rhythm lasting over 7 days without stopping on its own. The study aims to better understand the use of this device system in managing symptomatic PsAF. Participants will undergo cardiac ablation using pulsed field ablation with the VARIPULSE catheter and TRUPULSE generator equipped with VARIPULSE Pro software. This treatment focuses on pulmonary vein isolation to manage PsAF symptoms. The study involves one treatment group receiving this investigational device combination. During the study, participants will have several intraoperative measurements such as total procedure time, pulsed field application time, number of applications, and fluoroscopy time. Researchers will monitor acute effectiveness and safety outcomes including serious and non-serious adverse events up to three months post-procedure. The study collects data on pulmonary vein isolation durability and requires participants to comply with all pre-, post-, and follow-up testing and requirements. Total participation duration depends on follow-up schedules extending up to 90 days after the ablation.

Researchers are evaluating the safety and performance of the VARIPULSE pulsed field ablation (PFA) catheter compared to the FDA-approved FARAWAVE PFA catheter in adults with symptomatic persistent atrial fibrillation (PsAF). PsAF is a condition characterized by a continuous irregular and rapid heartbeat lasting more than 7 days without stopping on its own. This study aims to understand how these devices work to treat this ongoing heart rhythm problem. Participants with PsAF will be randomly assigned to receive catheter ablation treatment using either the VARIPULSE catheter or the FARAWAVE catheter. After undergoing the ablation procedure, participants will be followed and monitored for up to 12 months to assess outcomes. The treatments involve specialized catheters designed to apply pulsed field energy to the heart tissue to address abnormal rhythms. Throughout the study, participants will be observed for early adverse events within 7 days after the procedure and monitored for freedom from atrial tachyarrhythmia episodes starting from day 61. Quality of life will be evaluated at baseline, 6 months, and 12 months using a specific atrial fibrillation effect questionnaire. The study includes regular testing, follow-ups, and imaging to ensure participant safety and to measure treatment impact over time.