Valvular Heart Disease

Researchers are evaluating a new 10-minute cardiovascular magnetic resonance CMR imaging protocol designed to improve current CMR procedures for patients with various heart conditions, including coronary artery disease, cardiomyopathies, and other cardiac diseases. The study aims to develop a standardized, contrast-free imaging method that can be applied to about 70% of cardiac patients. The goal is to assess whether this shorter protocol enhances diagnostic decision-making and reduces healthcare costs. The study involves two groups healthy volunteers over 18 years old without significant cardiovascular or respiratory conditions, and patients over 18 years who require a clinically indicated CMR exam. The new protocol focuses on heart function and tissue characterization without using contrast agents. Researchers will compare the new 10-minute protocol to standard CMR imaging, evaluating its clinical feasibility, performance, and cost-effectiveness in different patient populations. Participants will undergo CMR scans using both the new and standard protocols. Researchers will monitor diagnostic results, scan completion rates, scan sequence times, adverse events, and cost differences between methods. Various heart tissue measurements and reproducibility between different readers and scanners will also be assessed. The study spans from 2019 to 2025, with ongoing safety monitoring during imaging sequences and a focus on improving the efficiency and quality of cardiac imaging.

This research aims to evaluate the use of two advanced transcatheter aortic valve implantation TAVI devices, JenaValve and J-Valve, for patients with pure aortic regurgitation AR. AR patients, who often face high risks with open heart surgery, have different heart flow and structure compared to those with aortic stenosis. The study focuses on understanding the unique challenges and follow-up needs, including the potential for leaflet thrombosis, in patients treated with these dedicated TAVI devices. Participants in this observational study receive TAVI treatment using either the JenaValve or J-Valve systems. These devices have special anchoring mechanisms designed for pure AR cases. The study involves detailed imaging assessments, including magnetic resonance imaging MRI and computed tomography CT, performed at baseline, within one month after the procedure, and during follow-up periods at six months and one year. Echocardiographic evaluations and clinical event tracking are also conducted immediately after, and up to 12 months post-procedure. Throughout the study, participants undergo extensive monitoring with various imaging tests to detect leaflet thrombosis and assess heart function over time. Researchers will review cardiovascular events like stroke, heart attacks, and hospitalizations for heart failure. Patient symptoms and functional status will be evaluated at multiple time points up to one year. The study provides careful observation of device performance and patient outcomes over a prolonged period, lasting until September 2028.

Researchers are evaluating the GeminiOne Transcatheter Edge-to-Edge Repair TEER System for adults with severe, symptomatic mitral regurgitation MR. This multi-center, non-randomized clinical trial aims to confirm the safety and effectiveness of the device in patients who are at high risk for surgical intervention or have not responded to other therapies. The study is sponsored by Sierra Valve LLC and involves participants from centers in the United States, Canada, and Europe. Participants will receive the investigational GeminiOne TEER System, which includes a clip implant made from specialized alloys and a delivery system designed for left atrial placement through transfemoral trans-septal access. Up to 15 subjects will be treated initially, and the study will last about 72 months with a 12-month enrollment period. After implantation, participants will be followed for 60 months to monitor outcomes. During the study, participants will undergo assessments including echocardiography, functional status evaluation, and quality of life questionnaires at 30 days, 12 months, and annually thereafter. Researchers will track major adverse events, mortality, stroke, rehospitalizations, and changes in heart function and symptoms. Safety and procedural success will be monitored closely during the first 30 days post-implant, with continued evaluation throughout the follow-up period.

Researchers are evaluating the effects of transcatheter aortic valve implantation TAVI on patients with severe degenerative aortic stenosis, a condition where the hearts aortic valve narrows and affects blood flow. The study also includes a control group of patients with aortic stenosis who have not undergone valve replacement. The goal is to measure changes in heart tissue and function by comparing those treated with TAVI to patients receiving only medication. Participants will be divided into two groups one group will undergo TAVI following standard clinical procedures along with optimal medication therapy, while the control group will receive only optimal medication treatment. The recommended medications include several categories such as SGLT2 inhibitors, angiotensin receptor-neprilysin inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and individualized diuretics. Each participant will have a special PETCT scan using the FAPI tracer at the start of the study and again six months later to assess heart tissue changes. Throughout the study, enrolled patients will be monitored with FAPI-PET scans to measure myocardial uptake values at baseline and six months after treatment or enrollment. The study will track the activity of heart fibroblasts, structural remodeling of the heart muscle, and changes in cardiac function. Participants are followed for at least six months to evaluate these outcomes, with all clinical and imaging assessments designed to compare the effects of TAVI and medication-only therapy on heart health.

Researchers are conducting a prospective, randomized, controlled, international study involving up to 1054 adults with severe native calcific aortic stenosis who need Transcatheter Aortic Valve Replacement TAVR. The trial aims to compare the DurAVR4 THV System with commercially available Transcatheter Heart Valves from the SAPIEN or Evolut series. Additionally, up to 446 low-risk subjects will be enrolled in a continued access cohort, and a separate registry will follow 150 subjects with failed surgical bioprosthetic valves requiring valve-in-valve TAVR using the DurAVR4 THV. Participants will be randomized to receive either the DurAVR4 THV System or a commercially approved SAPIEN or Evolut THV device for native aortic stenosis. Those in the valve-in-valve registry cohort will receive only the DurAVR4 THV. Subjects will be followed for up to 10 years in the randomized cohorts and 5 years in the valve-in-valve registry. The study involves device implantation through TAVR procedures performed under clinical guidelines. During the study, participants will be monitored for outcomes including a composite of all-cause mortality, stroke, and cardiovascular hospitalization after one year. Secondary measures include mortality, disabling stroke, bleeding, vascular complications, and acute kidney injury within 30 days post-procedure. Follow-up visits and assessments will track participant health and device performance over the long term to evaluate safety and effectiveness.

Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index MDPI to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass CPB. This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.

This research aims to better understand mitral and tricuspid valve leakage regurgitation in patients diagnosed with transthyretin amyloid cardiomyopathy ATTR-CM. It focuses on measuring how common these valve problems are, their severity, and how they affect patient outcomes. The study also seeks to create new standards for grading this leakage that fit the unique heart function changes seen in ATTR-CM, improving on current methods that do not account for this specific condition. As an observational study, it will gather detailed heart ultrasound echocardiographic data from patients with ATTR-CM, focusing on quantitative and semi-quantitative measures of mitral and tricuspid regurgitation. There are no experimental treatments instead, the study collects information to better define and predict the impact of valve leakage in this condition. The research is conducted internationally across multiple centers, starting in 2025. Participants will undergo comprehensive baseline heart ultrasound assessments within about six months of diagnosis and then be followed for up to 60 months. Researchers will track outcomes including all-cause death, cardiovascular death, and hospitalizations due to heart failure. The study involves regular clinical follow-up and data collection to analyze the relationship between valve leakage measures and patient prognosis under typical care conditions.

This trial studies adults aged 50 to under 80 with mild or moderate calcific aortic valve stenosis and elevated lipoproteina levels. Researchers are assessing the safety, tolerability, and ability of pelacarsen TQJ230 given once monthly by injection to slow the progression of this heart valve condition. The study compares pelacarsen to a placebo in a randomized, double-blind design. Participants receive either pelacarsen 80 mg or a matching placebo as a subcutaneous injection monthly. They continue treatment and monitoring for up to 36 months to observe changes in heart valve narrowing and calcium buildup. The study also tracks lipoproteina levels and clinical heart-related events during this period. Throughout the study, participants will have regular assessments including imaging to measure aortic valve function and calcium score, blood tests for lipoproteina, and monitoring for safety. The main outcomes analyzed after 36 months include changes in valve jet velocity and calcium score, alongside clinical events. Participants remain under medical care while being observed for any effects of the study drug or placebo.

Researchers are evaluating whether stopping secondary antibiotic prophylaxis SAP is not worse than continuing SAP in preventing worsening of rheumatic heart disease RHD in children and adolescents. This Phase 3 trial focuses on participants aged 5 to 20 years who have mild RHD and have already received at least two years of SAP. The goal is to see if stopping SAP affects heart disease progression compared to continuing treatment. The study is randomized and controlled with a single masking approach. Participants will be randomly assigned to either stop SAP or continue receiving monthly intramuscular benzathine benzylpenicillin G BPG injections for two years. Dosage is based on weight, with children under 30 kg receiving 600,000 IU and those 30 kg or above receiving 1.2 million IU every 28 days. The control group continues the standard care of monthly BPG injections, while the intervention group receives no prophylaxis for the same period. During the study, participants will be monitored for two years to assess the progression of RHD using echocardiographic evaluations based on the 2023 World Heart Federation criteria. Blinded adjudicators will review heart imaging results to determine disease changes. Researchers will also analyze outcomes for subgroups with either normalized or stable mild RHD and explore differences based on prior prophylaxis routes. The trial spans from enrollment through the end of the 2-year treatment period, with safety and disease progression closely followed.

Researchers are assessing the safety and performance of the TriClip System for treating tricuspid regurgitation in a real-world, contemporary setting. This observational, post-market study involves multiple centers worldwide and uses the commercially available device according to its approved uses to gather real-world data. Participants who are eligible for the TriClip procedure will be enrolled and followed over time. The study includes follow-up visits at hospital discharge, 30 days, 6 months by telephone, 12 months, and then annually up to 5 years. A subset of up to 250 participants will undergo additional imaging with cardiac-gated CT scans at baseline and 12 months to evaluate heart remodeling. An independent core laboratory will review echocardiograms to assess device performance. During the study, participants will undergo clinical assessments before the procedure to confirm eligibility. Researchers will monitor peri-procedural adverse events through 30 days post-procedure and evaluate the grade of tricuspid regurgitation and quality of life improvements at 30 days. Follow-ups over several years will help track long-term safety and device performance. Participants are expected to attend scheduled visits and assessments as part of this evaluation.