Roslyn

Researchers are studying real-world patient characteristics, treatment patterns, and both short- and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy HCM across the United States and Europe. The study focuses on patients receiving mavacamten, other treatments for obstructive HCM, or no treatment due to intolerance or prior treatment failure. The U.S. portion evaluates the safety of mavacamten in this setting, while the European part assesses both its effectiveness and safety. Participants receive treatments as part of standard care, either mavacamten or other medications such as beta-blockers, non-dihydropyridine calcium channel blockers, or disopyramide. Treatments are prescribed by physicians according to routine clinical management. The study observes outcomes over time without altering prescribed care. During the study, participants are monitored for changes in heart function, symptoms, and adverse events through clinical assessments including echocardiography and patient-reported questionnaires. Researchers evaluate heart failure events, heart function measures like left ventricular outflow tract gradient and ejection fraction, arrhythmias, hospitalizations, mortality, and quality of life scores. Data is collected at baseline and followed for up to five years to understand real-world treatment effects and safety.

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 studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Researchers are collecting clinical data on patients with symptomatic mitral valve disease, including mitral regurgitation, mitral stenosis, and mixed mitral valve disease. This observational registry aims to improve understanding of the effects of correcting symptomatic mitral valve disease on patient outcomes, particularly in those who may be candidates for Transcatheter Mitral Valve Replacement TMVR. The data may also support future regulatory or reimbursement decisions related to the Cephea Mitral Valve System. Participants include patients with symptomatic mitral valve disease who could be considered for transcatheter mitral valve replacement, based on evaluation by a specialized heart team. The study records information without assigning treatments, focusing on those judged more suitable for TMVR than conventional surgery or other therapies like transcatheter edge-to-edge repair TEER. There are no specific interventions administered as this is an observational registry. Participants provide informed consent and agree to follow study requirements, allowing ongoing data collection during their clinical care. The study monitors patients from enrollment through up to two years of follow-up to assess clinical outcomes related to mitral valve disease management. Data collected includes health status, treatment decisions, and other relevant clinical information to better understand the impact of TMVR candidacy on patient health over time.

Researchers are evaluating the safety and effectiveness of the AGENT Drug-Coated Balloon AGENT DCB compared to the standard care involving drug eluting stent DES andor balloon angioplasty in patients with new de novo coronary artery lesions. The study is prospective, multicenter, open-label, and randomized. It includes a pharmacokinetic PK sub-study and an intravascular ultrasound IVUS sub-study to gather additional data. Participants are assigned to one of several groups based on lesion types such as small vessels, bifurcation side branches, and long lesions. They receive either the AGENT DCB or standard care treatments including drug eluting stents or plain old balloon angioplasty POBA. The study compares these treatments in parallel groups according to the specific lesion characteristics. During the study, participants undergo the assigned procedure followed by protocol-required evaluations and follow-up visits to monitor outcomes. Researchers will assess the primary outcome of target lesion failure rate at 12 months. Participants are monitored for safety and effectiveness, with ongoing assessments throughout the study duration which continues until March 2032.

Researchers are conducting an international, multicenter, observational study to assess the performance of the Cordio HearO system in patients with symptomatic chronic heart failure. This non-interventional, prospective, single-arm study aims to collect patient voice recordings to analyze the sensitivity and unique patient noise reduction UPNR capabilities of the HearO device. The study is sponsored by Cordio Medical and focuses on monitoring heart failure events over time. The study consists of two periods a Run-In period where patients submit daily recordings to establish a baseline, followed by a Core period where patients continue daily submissions for up to 24 months or until the study ends. There is no active treatment or intervention beyond data collection using the HearO app, which records patient utterances for later analysis. Participants will submit daily voice recordings throughout the study duration. Researchers will monitor heart failure events, defined as first usable and adjudicated heart failure events, as the primary outcome. The study involves regular data collection without additional interventions, focusing on patient adherence to daily use of the app. The total observation period per participant may last up to 24 months or until a predefined number of heart failure events have occurred.

Researchers are conducting a prospective, international multi-center registry study to gather long-term clinical data on adult patients undergoing percutaneous coronary intervention PCI with drug-coated balloons DCB for new or untreated coronary artery disease. The study aims to evaluate how well drug-coated balloons perform in treating these heart artery conditions by tracking clinical outcomes over time. The registry collects data from multiple centers where clinical care and interventions such as the choice of drug-coated balloon, vessel preparation, and additional medications are decided by treating physicians based on standard care practices. No experimental treatments are assigned by the study. All participating sites submit their information into a centralized database managed by Emory University. Participants health outcomes are followed starting from hospital discharge, then at 30 days, 6 months, 12 months, and annually up to 5 years afterward. Researchers monitor events including target lesion failure, heart attacks, death, repeat procedures, vessel failure, thrombosis, and bleeding. This long-term observation helps to understand the safety and effectiveness of drug-coated balloons in real-world medical practice.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating imaging methods used after left atrial appendage closure LAAC with the Watchman FLX device to monitor device characteristics. The study compares the current standard method, transesophageal echocardiogram TEE, which involves inserting an ultrasound probe into the esophagus under sedation, with cardiac computerized tomography angiography cardiac CTA, a non-invasive scan using X-rays and contrast dye. This research aims to determine how well cardiac CTA performs compared to TEE for detecting device-related issues such as leaks and thrombosis. Participants will undergo both TEE and cardiac CTA on the same day, 90 days after their LAAC procedure. TEE will be done using a 3D probe capturing multiple views of the heart and device, while cardiac CTA will be performed with ECG gating and contrast timed for optimal imaging of the left atrium and device. The study involves one group of patients who have received the Watchman FLX device as part of their treatment. Participants will be followed for one year starting from their LAAC procedure day. They will have the standard TEE and cardiac CTA scans at 90 days post-procedure, a routine follow-up visit, and a brief phone check-in at one year. Researchers will measure device-related outcomes such as leaks and thrombus presence using both imaging methods, as well as device size and compression. Safety events will also be tracked shortly after the procedure.

Researchers are evaluating the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with symptomatic severe tricuspid regurgitation who are at intermediate or higher risk of death from tricuspid valve surgery. This prospective, multicenter, randomized, controlled pivotal trial compares transcatheter tricuspid valve repair plus optimal medical therapy OMT to OMT alone. The study aims to improve outcomes in patients with severe tricuspid valve disease through this novel treatment approach. Participants will be randomly assigned to receive either the Edwards PASCAL transcatheter valve repair system combined with OMT or OMT alone. Some patients who are not eligible for randomization may still receive the Edwards PASCAL system with OMT in single-arm or continued access study groups. Follow-up visits will be conducted at hospital discharge, 30 days, 3 months, 6 months, and annually up to 5 years to monitor progress and outcomes. During the study, participants will undergo assessments including quality of life questionnaires, heart function measurements, and monitoring for events such as mortality, heart failure hospitalizations, and need for additional heart interventions. Researchers will track changes in tricuspid regurgitation severity and right ventricular size, as well as major adverse events. The primary outcome focuses on a composite of mortality, heart device implantation or transplant, valve interventions, hospitalizations, and quality of life improvements at 6 months. Safety and effectiveness will be evaluated throughout the study duration, which may last up to 12 years.