PROGRESS Trial: Management of Moderate Aortic Stenosis (AS) by Clinical Surveillance or TAVR
- Recent studies suggest that moderate AS is associated with increased mortality and morbidity, especially when LV function is already reduced. The rate of progression from mild-moderate AS to more severe AS is highly variable and unpredictable and some subgroups of patients with moderate AS are associated with a worse prognosis.
- Current ACC/AHA guidelines for the management of patients with valvular heart disease call for ongoing clinical surveillance of patients with moderate aortic stenosis even if they are symptomatic or demonstrate evidence of cardiac dysfunction/damage.
- The PROGRESS study will randomize patients who are >65 years old with moderate aortic stenosis and symptoms or evidence of cardiac dysfunction/damage to either transfemoral TAVR with the Edwards SAPIEN 3 valve family or clinical surveillance.
- Study patients will be followed annually for 10 years.
- Patients enrolled in the clinical surveillance arm may undergo TAVR if they meet guideline-recommended criteria for the timing of aortic stenosis intervention.
- OHI was the first site in Oklahoma to enroll in this global study and continues to consistently enroll patients.
ALLIANCE Trial: Establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in patients with symptomatic, severe, calcific aortic stenosis (SAS)
- This study is evaluating the next generation Edwards SAPIEN X4 transcatheter heart valve in patients who meet guideline-recommended treatment for transcatheter aortic valve replacement.
- The SAPIEN valve X4 offers new leaflet tissue treatment (RESILIA) and will assess the ability to align the valve allowing coronary access as well as adjusting the valve size to fit the patient’s anatomy without affecting leaflet performance.
- Patients with trileaflet and bicuspid aortic anatomies may be eligible and soon, aortic valve-in-valve patients will be considered.
- Study patients will be followed annually for 10 years.
- OHI was the third center in the world to use this valve.
CLASP II TR Trial: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
- To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local heart team.
- 350 patients with severe TR will be randomized at up to 75 investigational sites in the US, Canada, Europe and other regions in a 2:1 randomization.
The CORCINCH-HF Trial: A multi-center randomized clinical trial designed to evaluate the safety and efficacy of the AccuCinch System in patients with congestive heart failure.
- Patients participating in this study will receive treatment with the AccuCinch System and guideline-directed medical therapy (GDMT) or GDMT alone.
- Implantation of the AccuCinch left ventricular restoration device, a flexible implant is attached to the inner wall of the heart’s left ventricle and then cinched
- As the only completely transcatheter procedure, designed to restore, support and strengthen the enlarged left ventricle, The AccuCinch System may help reduce symptoms, improve quality of life, improve cardiac function and potentially increase life expectancy
- Early data indicates that AccuCinch may initiate a process of favorable reverse left ventricular remodeling that persists beyond the index procedure
- Study patients will be followed for 5 years.
For additional information visit - Heart Failure Treatment Options and Clinical Trials | Ancora Heart
The Mitral II Study: A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease
- The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with the Commander delivery system in patients with severe symptomatic mitral annular calcification who are not candidates for standard mitral valve surgery.
- Patients will enter one of 2 arms in this study: “Transseptal Valve-in-MAC” (ViMAC) treatment arm or a “Natural History of Disease Registry” - medical treatment only which will include patients who meet inclusion criteria but can’t receive ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria.
- Potential study patients must be 18 years or older have severe mitral annular calcification with severe mitral stenosis (narrow mitral valve) or severe mitral regurgitation (leaky mitral valve) that is symptomatic, and the Heart Team agrees that valve implantation will likely benefit the patient.
- Study patients will be followed for 5 years.
- The study is sponsored by the Mayo Clinic and Oklahoma Heart Institute is one of up to 25 sites nationally that are participating.
EMPOWER Trial: TheCarillon Mitral Contour System® in Treating Heart Failure with at Least Mild Functional Mitral Regurgitation
- Total of 300 subjects will be randomized at up to 75 sites in the US, Canada, Europe, and Australia
- The Carillon System is a minimally invasive treatment option designed to treat heart failure and functional mitral regurgitation (FMR), which occurs when the heart’s valves do not properly close, resulting in blood leakage. FMR can lead to heart failure
- To learn more about the EMPOWER Sturdy, visit cardiacdimensions.com/patients-empower-study
- To learn more about the Carillon Mitral Contour System®, visit cardiacdimensions.com/patients
Envision IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation (TAVR)
- ENVISION is a prospective, multi-center clinical investigation at up to 135 sites globally
- The objective of this clinical investigation is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.
- The trial will register participants in three separate cohorts: (1) a pivotal randomized cohort, (2) a valve-in-valve (ViV) cohort and (3) a bicuspid cohort.
- The Randomization Cohort will enroll approximately 1500 subjects and will be randomized between the Navitor TAVI Implantation System (test arm) and any commercially available transcatheter aortic valve system (CAV) (control arm) in a 1:1 ratio
STAR Trial: To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- The primary objective is to assess the acute and long-term safety and efficacy of the Siegel THV device in adult subjects with symptomatic, severe native calcific aortic stenosis eligible for the transcatheter aortic valve replacement.
- Participant randomizes to Siegel device or a commercially available TAVR device
SUPPORT II Trial: Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) (SUPPORT II)
- The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).
- The Supira System is a minimally invasive percutaneous ventricular assist device (pVAD) that is intended to provide temporary hemodynamic support (≤ 4 hours) to patients undergoing HRPCI. The Supira Catheter is inserted percutaneously through the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with the pump outlet remaining in the ascending aorta. The pump portion of the Catheter compresses during insertion in the Introducer Sheath and re-expands during use. It actively unloads the left ventricle by pumping blood from the ventricle into the ascending aorta and systemic circulation.
TEAM HF Trial: Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure (TEAM-HF)
- The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.
- Patients with heart failure (HF) suffer from a high degree of morbidity and mortality. Left ventricular assist device (LVAD) therapy has become the standard of care for the treatment of advanced HF patients who are deemed to be dependent on continuous intravenous inotropes, extending life expectancy, enhancing overall quality of life, and improving functional capacity.
- The TEAM-HF IDE trial will enroll approximately 850 subjects with New York Heart Association (NYHA) Class IIIB/IV HF who had a prior heart failure hospitalization and an elevated mean PAP secondary to left ventricular failure. Elevated mean PAP will be identified using an implanted PAP monitoring sensor, the CardioMEMS PA Sensor.
stAAAble Study: Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.
- The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.
- The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.
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For questions about current study or trial participation, or to see if you may be a candidate, please call 918-592-0999 and ask to speak with a Research Coordinator.