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.
ENCIRCLE Trial: Pivotal trial to establish the safety and effectiveness of percutaneous transcatheter mitral valve replacement (TMVR) using the Edwards SAPIEN M3 valve
- Enrolling 500 patients with symptomatic, >=3+ mitral regurgitation or mitral annular calcification (MAC) with moderate MR and moderate MS, or severe MS who are not suitable for surgery or MitraClip.
- Fully percutaneous transcatheter mitral valve replacement (TMVR) via a femoral venous/transseptal approach.
- Study patients will be followed annually for five years.
- OHI is currently the second-leading enroller in this study.
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.
CardiAMP Cell Therapy for Heart Failure Trial: A Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells in Patients with Post Myocardial Infarction Heart Failure:
- Evaluate stem-cell therapy in patients with heart failure due to previous ischemic HFrEF.
- Patients with New York Heart Association class II or III heart failure symptoms, despite optimal medical and device therapy, in the setting of ischemic cardiomyopathy (LVEF >= 20% and <=40).
- In the treatment arm, patients will receive intramyocardial injections (performed in the cardiac catheterization laboratory) of autologous bone marrow derived mononuclear stem cells (stem cells obtained from the patient’s own bone marrow on the day of treatment).
- The primary outcome will be measured by improvement in a composite outcome of survival, re-admissions and six-minute walk distance at 12 months. A variety of secondary endpoints (including improvement in left ventricular function) will also be studied.
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.
Protect Head to Head Trial: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device
- Emboliner embolic protection device to be used during TAVR procedures for stroke prevention
- Study patients are randomized to one of two embolic protection devices
- This study is comparing the Emboliner embolic protection device to the Sentinel Cerebral Protection System
- Enrolling 540 study patients who are eligible for treatment of symptomatic severe aortic stenosis using an FDA-approved TAVR valve according to current guidelines
- Study patients are followed for 30 days
ALT-FLOW II Trial: A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System
- This trial is assessing the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the treatment of patients with heart failure with preserved or mildly reduced ejection fraction who remain symptomatic despite guideline-directed medical therapy (GDMT)
- The APTURE shunt is a metal device that is placed in the heart to create a channel allowing a small amount of blood to flow from a heart chamber with elevated pressure-the left atrium, to a heart chamber with lower pressure-the right atrium, via a blood vessel-the coronary sinus.
- The shunting of blood is intended to relieve the elevated pressure which can cause symptoms associated with preserved heart failure (HFpEF) or mildly reduced heart failure (HFmrEF)
- Study patients are randomized to the APTURE transcatheter shunt system or sham procedure
- If randomized to the sham-control arm of study, study patients will be eligible to receive the investigational APTURE shunt when they complete their 1-year follow up visit.
- Enrolling 100 study patients who have symptomatic heart failure
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.
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