Arrhythmia

Researchers are evaluating two different pacing methods for patients with slow heart rates, called bradycardia. This study compares the common right ventricular pacing approach with a newer physiological pacing method that includes His bundle and left bundle area pacing. The trial aims to better understand how these pacing techniques affect patient outcomes, including mortality and heart failure morbidity, in a large group of 2600 patients. Participants will receive a pacemaker implant and be randomly assigned to either right ventricular pacing or physiological pacing. The physiological pacing may involve His bundle pacing or left bundle pacing, but if these are not successful, biventricular pacing will be used. A subgroup of 500 participants will take part in an optional echocardiographic sub-study to assess heart function changes over a 24-month period. Throughout the study, patients will be assessed at baseline and every six months after randomization, with follow-up lasting up to 78 months. Researchers will monitor outcomes such as mortality, heart failure events, device-related safety issues, patient quality of life, symptoms, and pacemaker-derived data like arrhythmias and activity levels. The echocardiographic sub-study will measure specific heart function changes to understand pacing-induced cardiomyopathy. Participants involvement includes implantation, regular follow-up visits, questionnaires, and optional imaging assessments.

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 in patients with various arrhythmias. This device is studied in individuals undergoing clinically indicated catheter mapping and ablation procedures for managing arrhythmias such as ventricular tachycardia, atrial fibrillation, and premature ventricular contractions. Participants will undergo catheter mapping and ablation using the investigational multi-electrode mapping catheter during their scheduled procedures. The catheter is used to perform high-density mapping of the hearts electrical activity to guide treatment. The study focuses on the devices safety, including serious adverse events within 7 days post-procedure, and its ability to complete all required pre-ablation mapping tasks. Evaluation includes physician assessments of the catheters deployment, maneuverability, and signal quality. During the study, participants will be monitored for safety outcomes up to 7 days after the procedure. Researchers will collect data on adverse events, mapping completion, and device performance. Participants must comply with all pre-procedure, post-procedure, and follow-up testing and requirements. The studys total duration includes the procedure day and a 7-day follow-up period to assess device-related safety and effectiveness parameters.

Researchers are evaluating the long-term safety and effectiveness of the FDA-approved VARIPULSE catheter system for pulmonary vein isolation PVI in adults with symptomatic paroxysmal atrial fibrillation PAF. This device-based study focuses on participants who have not responded well or cannot tolerate at least one Class I or III antiarrhythmic drug and are candidates for catheter ablation. The goal is to monitor the outcomes of using this specific catheter system in managing PAF. Participants will undergo electrophysiology mapping and pulsed field ablation PFA using the VARIPULSE catheter combined with the TRUPULSE generator to perform pulmonary vein ablation. The study is a single-group design where all participants receive this intervention to treat their symptomatic PAF. The ablation procedure is followed by a long-term observation period to assess safety and effectiveness. During the study, participants will be closely monitored for early adverse events within 7 days after the ablation procedure and for freedom from documented atrial tachyarrhythmia episodes from day 61 up to 1095 days post-procedure. Assessments include follow-up testing and compliance with study requirements over this extended period to evaluate both short-term and long-term outcomes. The total study duration extends through 2030, with ongoing safety and effectiveness evaluations.

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 the safety and effectiveness of the Dual Energy THERMOCOOL SMARTTOUCH SF catheter combined with the TRUPULSE generator for treating ventricular arrhythmias. This study focuses on whether the abnormal heart rhythms, including premature ventricular complexes and sustained monomorphic ventricular tachycardias, can be successfully treated using a specific procedural workflow during cardiac ablation. The trial also monitors participant safety by checking for any complications after the procedure. Participants undergo catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH SF catheter with the TRUPULSE generator, which delivers radiofrequency and pulsed field energy mainly as RFPF stacking applications according to the studys procedural workflow. The study groups include those being treated for premature ventricular complexes and different types of sustained ventricular tachycardia. The study tracks the procedures effectiveness and safety over several months following the ablation. During the study, participants are monitored with assessments including electrocardiographic data review, tracking of adverse events up to six months post-procedure, and intraoperative measurements such as procedure time, mapping details, and ablation parameters. Researchers measure the success of the procedural workflow at 3 months for premature ventricular complexes and at 6 months for ventricular tachycardia cases. Safety is closely observed up to 7 days and 6 months after the ablation to detect any adverse effects or complications.

Researchers are evaluating the use of the pulsed field ablation system, which includes the VARIPULSE Catheter, TRUPULSE Generator, and the new VARIPULSE Pro software, for treating participants with paroxysmal atrial fibrillation PAF and persistent atrial fibrillation PsAF. The study focuses on the workflow effectiveness of this system during cardiac ablation procedures aimed at managing irregular heartbeats in these populations. Participants will undergo pulsed field ablation PFA using the VARIPULSE Catheter and TRUPULSE Generator with the VARIPULSE Pro software. The study involves a single group receiving this device-based intervention to treat symptomatic PsAF or PAF through pulmonary vein isolation PVI alone or combined with cavotricuspid isthmus-dependent atrial flutter ablation. The treatment is delivered during an ablation procedure with the device system. During the study, participants will be monitored for various outcomes including acute effectiveness during the procedure, durability of pulmonary vein isolation at 3 months, and procedural details such as pulsed field application time and number of applications. Safety assessments include monitoring for serious and non-serious adverse events up to 3 months post-procedure, neurological evaluations using MRI and cognitive scales, and assessment of pulmonary vein stenosis. The total participation duration extends at least 3 months post ablation for follow-up and outcome measurement.

Researchers are evaluating the use of the pulsed field ablation PFA system, which includes the VARIPULSE catheter, TRUPULSE generator, and the new VARIPULSE Pro software, for treating participants with persistent atrial fibrillation PsAF. This condition involves an irregular, rapid heart rhythm lasting more than 7 days that does not stop on its own. The study aims to investigate the clinical workflow and effectiveness of this system during cardiac ablation procedures for PsAF. Participants selected for this study will undergo pulmonary vein isolation using the pulsed field ablation system with the specified devices and software. The ablation procedure is intended to manage symptomatic persistent atrial fibrillation, especially in those who have failed at least one antiarrhythmic drug. The study does not include a comparison group and focuses on a single group receiving the PFA treatment. During the study, participants will be monitored for several outcomes including acute procedural success during the ablation, durability of pulmonary vein isolation up to 3 months, and details such as the time and number of pulsed field applications. Safety assessments include monitoring serious and non-serious adverse events, neurological status through scales like the Mini Mental State Examination and NIH Stroke Scale, and MRI evaluations for cerebral emboli. Follow-up and testing will occur before, during, and up to 3 months after the ablation procedure, with the overall participation lasting several months.

This trial is studying how safe and effective the VARIPULSE catheter system is for treating persistent atrial fibrillation PsAF, a heart rhythm disorder. It focuses on participants undergoing catheter ablation procedures that isolate veins in the heart, specifically pulmonary vein isolation PVI and superior vena cava isolation SVCI, with or without posterior wall isolation PWI. The study also looks at safety for participants receiving a left atrial appendage occlusion LAAO procedure during the catheter ablation to reduce stroke risk. Participants will be treated with the VARIPULSE catheter system, which delivers pulsed field ablation, using the VARIPULSE bi-directional catheter and TRUPULSE generator. The study has two groups one undergoing PVI and SVCI, and another undergoing PVI, SVCI, plus PWI. Some participants may also receive the LAAO procedure using commercially available devices as per device instructions. All participants will be followed for up to 36 months after their procedure. During the study, participants will undergo catheter ablation treatment and may receive the LAAO procedure if applicable. Researchers will monitor safety by tracking early adverse events up to 7 days post-procedure and will assess how well the treatment prevents atrial tachyarrhythmia episodes from day 61 to 180 and up to one year. Quality of life will be measured at baseline and 12 months after treatment. Participants need to comply with pre-, post-, and follow-up testing throughout the study and will be observed for up to three years in total.