Roslyn

Researchers are evaluating real-world patient characteristics, treatment methods, and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in the United States and Europe. The study includes patients receiving mavacamten, other treatments, or no treatment due to intolerance or treatment failure. The US sub-study focuses on safety of mavacamten, while the European sub-study assesses both safety and effectiveness of mavacamten in everyday care. Participants may receive mavacamten or standard treatments like beta blockers, non-dihydropyridine calcium channel blockers, or disopyramide as prescribed by their doctors. The study observes these groups over time in routine clinical settings without altering their care. The study includes two main groups based on treatment type and monitors outcomes up to five years. Participants undergo evaluations including echocardiograms, heart function assessments using New York Heart Association (NYHA) class, left ventricular outflow tract gradient measurements, and patient-reported health questionnaires. Researchers also track heart failure events, arrhythmias, major cardiovascular events, hospitalizations, mortality, and biomarkers like NT-proBNP and cardiac troponin. Follow-up varies by region, lasting up to 18 months in Europe and up to 5 years in the United States.

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 efficacy and safety of finerenone compared to a placebo in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international study is a randomized, double-blind, placebo-controlled trial designed to assess how finerenone affects morbidity and mortality in these patients. Participants are randomly assigned to receive either oral finerenone or a matching placebo. The study is event-driven and ongoing for up to about 30 months, focusing on heart failure events and cardiovascular deaths. The trial includes careful monitoring of adverse events and treatment discontinuation due to side effects. During the study, participants will be closely monitored for heart failure events, cardiovascular deaths, and changes in symptoms using the Kansas City Cardiomyopathy Questionnaire. Regular assessments will track serious adverse events and safety. The total duration of participation may last up to approximately 30 months, with ongoing follow-up to understand long-term effects of the treatment.

Researchers are collecting clinical data on adults with symptomatic mitral valve disease, including those with mitral regurgitation, mitral stenosis, or mixed mitral valve disease. This observational registry aims to better understand the effects of correcting mitral valve disease on health outcomes, especially for patients who might be candidates for Transcatheter Mitral Valve Replacement (TMVR). The gathered information may also help guide future regulatory decisions for the Cephea Mitral Valve System. Participants include symptomatic patients considered suitable for TMVR by their heart care team, favoring this approach over conventional surgery or other therapies. The study will follow patients from enrollment for up to two years to observe their clinical progress. There are no specific treatments or interventions assigned by the study since it is observational. During the study, participants' health data will be collected regularly to monitor their condition and outcomes related to mitral valve disease correction. Follow-up includes reviewing clinical status and treatment effects over the two-year period. Participants must consent to data collection and follow-up visits, allowing researchers to evaluate the impact of TMVR candidacy on their health over time.

Researchers are evaluating the safety and effectiveness of the AGENT Drug-Coated Balloon (DCB) compared to standard percutaneous coronary intervention (PCI) treatments, which include drug eluting stents (DES) and/or balloon angioplasty, for patients with new (de novo) coronary artery lesions. This prospective, multicenter, open-label randomized controlled study focuses on patients with de novo target lesions in native coronary arteries. The study also includes pharmacokinetic (PK) and intravascular ultrasound (IVUS) sub-studies to gather additional data. Participants will be assigned to one of several groups receiving different treatments: small vessel subjects treated with AGENT DCB or DES, bifurcation subjects with side branches treated with AGENT DCB or DES/balloon angioplasty, and long lesion subjects treated with AGENT DCB or DES. Treatments are delivered via PCI, and the study compares the AGENT DCB device to the current standard of care using commercially available DES and plain old balloon angioplasty (POBA). During the study, participants will undergo regular follow-ups to monitor safety and treatment effectiveness. Researchers will assess the primary outcome of target lesion failure (TLF) rate at 12 months. Additional evaluations include angiographic assessments and adherence to protocol-required follow-ups. The total duration and detailed schedule of assessments will be conducted to ensure comprehensive monitoring of all subjects.

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 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 medicine's 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 for patients with symptomatic severe tricuspid regurgitation who are at intermediate or higher risk of death from tricuspid valve surgery. This pivotal, prospective, multicenter, randomized, controlled trial compares the Edwards PASCAL system plus optimal medical therapy (OMT) to OMT alone in treating tricuspid regurgitation. The study is led by Edwards Lifesciences and aims to improve patient outcomes using this device. Participants are assigned to one of several groups: receiving transcatheter tricuspid valve repair with the Edwards PASCAL system plus OMT, OMT alone, or transcatheter repair with the Edwards PASCAL system outside the randomized groups. The Edwards PASCAL device is delivered through a minimally invasive transcatheter procedure to repair the tricuspid valve. Follow-up visits occur at hospital discharge, 30 days, 3 months, 6 months, and then annually for up to 5 years to monitor patient progress and outcomes. Throughout the study, participants undergo evaluations measuring mortality, heart failure hospitalizations, need for additional heart procedures, and quality of life using the Kansas City Cardiomyopathy Questionnaire. Researchers will also assess heart function via ultrasound measurements and monitor adverse events. Participants will be closely followed over several years to track the long-term effects and safety of the Edwards PASCAL system combined with medical therapy compared to medical therapy alone.

Researchers are evaluating the safety and effectiveness of the Shockwave Reducer device in treating patients with refractory angina pectoris who have persistent symptoms despite maximum medical therapy and cannot undergo revascularization. The study focuses on those with reversible myocardial ischemia in the left coronary artery and includes a non-randomized registry for certain patients with issues in the right coronary artery, no obstructive coronary disease, or mobility limitations. This is a multicenter, randomized, double-blinded, sham-controlled clinical trial. Participants are randomly assigned in a 1:1 ratio to either receive the Shockwave Reducer implant or undergo a sham implantation procedure without the device. A third unblinded, non-randomized registry arm includes patients meeting specific criteria with reversible ischemia but not eligible for randomization. The study includes follow-up over six months to assess safety and effectiveness outcomes, including angina severity measured by the Canadian Cardiovascular Society (CCS) Angina Score. During the trial, participants will undergo evaluations to confirm eligibility and monitor heart function, ischemia, and symptoms using tests such as stress echocardiography, nuclear studies, or exercise tolerance tests. Researchers will review co-primary effectiveness and safety endpoints at six months. Patients are expected to maintain stable medication regimens and comply with follow-up visits to help assess the device's impact on angina symptoms and heart performance.