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 ReValve System as a treatment option for people with clinically significant mitral regurgitation who are suitable candidates for mitral valve surgery. This clinical study focuses on replacing the native mitral valve using this device, aiming to assess its technical success during the procedure. The study is in its early phase and sponsored by ReValve Solutions Inc. Participants will receive the ReValve System, a device designed to replace the mitral valve. This is a single-arm study where all participants undergo the investigational procedure with the device. There are no comparison groups or placebos involved. During the study, participants will be monitored for the technical success of the procedure. Assessments may include heart function tests such as echocardiograms and other cardiac imaging to evaluate valve performance. The study will continue until January 2028, with follow-up planned to understand the outcomes of the valve replacement.

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 heart's 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 PET/CT 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 evaluating the safety and effectiveness of the DurAVR4 biomimetic valve compared to other commercially available transcatheter heart valves (THVs) in adults with severe native calcific aortic stenosis who require Transcatheter Aortic Valve Replacement (TAVR). This prospective, randomized, controlled, multicenter international study includes subjects determined by the local Heart Team to benefit from TAVR. The study also includes a separate group of patients with failed surgical bioprosthetic valves who need valve-in-valve TAVR and are considered high surgical risk. Participants will be randomized to receive either the DurAVR4 THV system or a control THV from the SAPIEN or Evolut series. Up to 1054 subjects will be enrolled in the main randomized cohort and followed for 10 years. Additionally, up to 446 low-risk subjects will be randomized in a continued access cohort. A separate nested registry will enroll up to 150 high-risk subjects needing valve-in-valve TAVR who will only receive the DurAVR4 THV. Treatments are delivered by transcatheter implantation, and the study compares these devices in real-world clinical settings. During the study, participants will undergo assessments including mortality, stroke, and cardiovascular hospitalizations over one year as primary outcomes. Secondary outcomes include mortality, disabling stroke, bleeding, vascular complications, and kidney injury within 30 days following the procedure. Participants will be monitored with imaging and clinical evaluations, and safety will be followed for up to 10 years in the main cohort and 5 years in the valve-in-valve registry. The study aims to provide long-term data on these heart valve devices and their impact on patient health.

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.

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly subcutaneous injection, on slowing the progression of calcific aortic valve stenosis in adults aged 50 to under 80 years with elevated Lipoprotein(a) levels. This phase 2, randomized, double-blind, placebo-controlled multicenter trial aims to assess the efficacy, safety, and tolerability of pelacarsen compared to a matching placebo. The study is sponsored by Novartis Pharmaceuticals and focuses on patients with mild to moderate calcific aortic valve stenosis who are optimally treated for cardiovascular risk factors. Participants receive either pelacarsen 80 mg or a placebo via a prefilled syringe injected under the skin once every month. The study includes two groups: one receiving the active drug and the other receiving a placebo, both administered in the same way. The trial will last up to 36 months, during which patients will be monitored for changes in aortic valve function and calcium levels. Throughout the study, participants will undergo evaluations including measurement of peak aortic jet velocity and aortic valve calcium scores at 36 months. Additional assessments include changes in Lipoprotein(a) levels at 12 months and monitoring of fibrocalcific thickening of the valve and clinical events over the course of the trial. Safety will be closely monitored to ensure participants' well-being during the entire study period.

Researchers are evaluating the safety and effectiveness of a transcatheter aortic valve system for patients with severe aortic stenosis, a serious heart valve condition. This prospective, multicenter, single-arm clinical trial plans to enroll 120 patients aged 70 years or older who have been diagnosed with symptomatic severe aortic stenosis and are not suitable candidates for conventional surgery. The trial aims to measure all-cause mortality within 12 months after the valve implantation as the primary outcome. Participants will receive the transcatheter aortic valve replacement using the Silara SR Heart Valve System. The study involves a single treatment group where all patients undergo this procedure. After implantation, patients will be closely monitored at several time points including immediately post-operation, at 7 days or discharge, 30 days, 6 months, 12 months, and annually up to 5 years. These visits will assess valve function, procedural success, device performance, improvements in cardiac function and quality of life, and any complications. During the study, patients will have regular clinical follow-ups involving imaging tests such as ultrasound, laboratory tests, and safety evaluations to monitor heart valve performance and overall health. Researchers will collect detailed clinical data to analyze device success, cardiac function improvements, mortality rates, and major adverse events up to five years post-procedure. The total participation time includes follow-ups up to 5 years to evaluate long-term safety and effectiveness of the valve system.