Atrial Fibrillation

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 safety and effectiveness of a new device called the Globe Pulsed Field System in treating patients with symptomatic paroxysmal or persistent atrial fibrillation. This study focuses on a specific ablation method combining Pulmonary Vein Isolation with Box Isolation of Fibrotic Areas BIFA to address irregular heart rhythms. The goal is to assess how well this approach works and how safe it is over a 12-month period. Participants will receive treatment using the Globe Pulsed Field System, which involves ablation and atrial mapping procedures designed to isolate problematic heart tissue. The study tracks the safety of this device within the first 7 days post-treatment and evaluates its effectiveness over one year. Patients included have previously tried or could not tolerate at least one antiarrhythmic drug. During the study, participants will be monitored closely for safety and treatment success at regular intervals, including assessments of heart function and rhythm stability. The primary outcomes measured include treatment effectiveness after 12 months and safety within 7 days of the procedure. The trial will last up to three years, starting in June 2025 and ending in June 2028, ensuring comprehensive follow-up and evaluation of the devices impact.

Researchers are evaluating the use of dapagliflozin to reduce cardiovascular risk in women who have experienced hypertensive pregnancies. This randomized, placebo-controlled trial focuses on patients at high risk for adverse cardiovascular outcomes within five years after delivery. The study is a pilot-scale, single institution investigation aiming to assess the feasibility, acceptability, and effects of dapagliflozin during the postpartum period. Participants will be randomly assigned to one of two groups one group will receive dapagliflozin 10 mg daily for six months, while the other group will receive a daily placebo for the same duration. During the study, participants will attend four study visits and complete specific activities including daily blood pressure monitoring, weekly weight measurements, laboratory tests, and echocardiograms. After the six-month treatment period, participants will be followed remotely for one month. Throughout the trial, researchers will measure cardiovascular risk reduction scores at the start and after six months of treatment. Secondary outcomes include tracking patient adherence, barriers to adherence, loss to follow-up rates, and screening statistics over a two-year recruitment period. The total participation includes treatment and follow-up visits, with regular assessments to monitor health and gather data for evaluating the study drugs impact on cardiovascular risk.

Researchers are evaluating the safety, tolerability, and biomarker effects of VS-041 in people with Heart Failure with Preserved Ejection Fraction HFpEF, a type of heart condition where the heart pumps normally but is stiff. This Phase 1 trial aims to understand how VS-041 affects specific heart-related biomarkers and to monitor any treatment-emergent adverse events. The study is sponsored by Vasa Therapeutics and focuses on adults aged 50 and older diagnosed with HFpEF. Participants will be randomly assigned to receive either a high dose or low dose of VS-041, or a matching placebo tablet, taken twice daily. The treatment period lasts 28 days, during which safety, tolerability, and biomarker changes in the blood, including NordicPRO-C6, endotrophin, and NT-proBNP levels, will be closely tracked. Pharmacokinetic profiles of the drug will also be assessed to understand how the body processes VS-041. During the study, participants will undergo screening to confirm eligibility, including heart function tests and biomarker measurements. Throughout the 28-day treatment, researchers will monitor participants for side effects and changes in biomarkers. The main outcomes measured are adverse events and changes in serum biomarkers from baseline to Day 28. Participants must be willing to follow study procedures, including medication adherence and attending scheduled visits, to help assess the drugs safety and biological effects.

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.