Research

July 12, 2022 – Oklahoma Heart Institute, in partnership with the Oklahoma Heart Research & Education Foundation and Edwards Lifesciences, was the third center in the world to implant the next-generation Edwards Sapien X4 valve as part of the multicenter ALLIANCE trial. We performed three successful cases with this new valve.

This valve has several new features being evaluated in the ALLIANCE trial, including:

• RESILIA tissue technology with enhanced anti-calcification
• Commissural alignment to facilitate improved coronary access and better simulate natural flow conditions
• Novel frame and leaflet design to allow for adjustable sizing (0.5-1 mm increments in diameter)

The ALLIANCE trial is a multicenter trial evaluating this next generation valve with a goal of enrolling 765 patients across 65 centers in the U.S. and Canada. Patients with severe aortic stenosis at all risk levels will be enrolled and treated with Sapien X4 with standard follow-up out to 10 years.

April 26, 2022 - Mitral annular calcification (MAC) can be associated with severe mitral regurgitation, mitral stenosis or mixed disease (combined MR/MS) and result in debilitating heart failure symptoms and increased mortality. Surgery for these patients is very difficult, and there are no currently acceptable or approved transcatheter (non-surgical) options.

Oklahoma Heart Institute (OHI) recently performed the two first transcatheter mitral valve replacements (TMVR) in the world within the new MAC Registry of the ENCIRCLE trial. These procedures were done percutaneously (without surgery) from the femoral vein (main vein in the groin) with the patient’s hearts beating. The ENCIRCLE trial is evaluating TMVR in patients with severe mitral valve disease who are unsuitable for surgery or MitraClip, and is one of the leading trials of TMVR in the U.S.

February 15, 2022 – Oklahoma Heart Institute (OHI), in partnership with the Oklahoma Heart Research & Education Foundation and Edwards Lifesciences, treated the first patient in Oklahoma as part of the PROGRESS Trial.

This trial is a prospective, randomized, controlled trial to evaluate management of moderate aortic stenosis by clinical surveillance versus transcatheter aortic valve replacement (TAVR) using the Edwards Sapien 3 Ultra valve. OHI is the only center in Oklahoma participating in the study and the 4th center in the world to treat a PROGRESS trial patient.

Currently only patients with severe symptomatic aortic stenosis can undergo aortic valve replacement. The PROGRESS Trial is investigating if early intervention may help improve outcomes in patients with moderate aortic stenosis and clinical characteristics associated with worse prognosis.

October 25, 2021 - Oklahoma Heart Institute, led by Kamran Muhammad, M.D., is participating in the CardiAMP™ Cell Therapy Trial for Heart Failure, sponsored by the Oklahoma Heart Research & Education Foundation (OHREF). This therapy is studying the use of a patient's own stem cells in the treatment of ischemic heart failure (patients with previous heart attacks and reduced heart muscle function), using a personalized and minimally invasive approach.

Preliminary results suggest that women may be more likely than men to meet the criteria for study eligibility. The importance of including more women into this and other heart failure research programs is vital to understand and improve outcomes for all patients.

June 22, 2021 – Oklahoma Heart Institute (OHI), in partnership with the Oklahoma Heart Research & Education Foundation and Edwards Lifesciences, was the first center in the world to use the new Edwards PASCAL Precision system for treatment of severe mitral valve regurgitation (leaky heart valve) as part of the CLASP IID/IIF Pivotal Trial on May 25, 2021. This research trial is a prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to the Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for open-heart mitral valve surgery by the heart team and in patients with functional mitral regurgitation (FMR) on guideline-directed medical therapy (GDMT).

OHI is pleased to be the first center in the world to utilize the next-generation PASCAL Precision system. OHI is one of 65 major U.S. cardiac centers participating in the CLASP IID/IIF trial. Patients who are enrolled in this trial may be candidates for minimally-invasive, non-surgical transcatheter mitral valve repair to treat their leaky mitral valve with the Edwards PASCAL device.

OHI continues to be the leader in innovation for the treatment of heart disease in Oklahoma and the region.

Dec. 4, 2020 - Oklahoma Heart Institute’s structural heart disease program is pleased to participate in the CLASP II TR trial, sponsored by the Oklahoma Heart Research & Education Foundation (OHREF). The Edwards PASCAL transcatheter valve repair system is being studied in this trial to repair severely leaky tricuspid valves without surgery. Oklahoma Heart Institute – through the OHREF – is the only center in Oklahoma participating in pivotal research studies of non-surgical heart valve repair therapies.

June 25, 2020 – Oklahoma Heart Institute is participating in the SUMMIT Tendyne Trial which is sponsored by the Oklahoma Heart Research & Education Foundation (OHREF). The first three transcatheter mitral valve replacement (TMVR) procedures in Oklahoma were performed at Oklahoma Heart Institute as part of this pivotal clinical trial.

This technology offers a minimally invasive option for This technology offers a minimally invasive option for patients who are high-risk for open heart surgery to treating disabling mitral valve disease if they qualify for the research trial. Transcatheter mitral valve replacement allows for replacement of the failing mitral heart valve while the heart is beating, through a small chest incision.

OHREF is one of 35 major sites across the U.S. participating in the SUMMIT Tendyne Trial. Because we are participating in this sponsored trial, it allows us to offer new technology locally to our patients who qualify for this study.

Oklahoma Heart Institute continues to lead the way in cardiology care and minimally invasive structural heart disease therapy in Oklahoma and the region. Our team also performed the first transcatheter aortic valve replacement (TAVR) in Tulsa in 2012 and the first transcatheter mitral valve repair (MitraClip) in Tulsa in 2014.