As an academic medical center, our participation in clinical trials promotes continued leadership and extends care options to patients who would otherwise have few or no choices. The University of Kansas Health System heart care team is engaged in 2 such trials designed to bring new hope to patients with severe aortic stenosis – a life-threatening condition that results when the aortic valve narrows.
Trials exploring minimally invasive alternatives to open heart surgery
- The Medtronic CoreValve® SURTAVI Trial is a prospective, multicenter investigation to evaluate the safety and effectiveness of transcatheter aortic valve implantation in patients with severe, symptomatic aortic stenosis at intermediate surgical risk. For inclusion, patients must have an STS mortality risk score of 4-10% and severe aortic stenosis presenting with:
- Critical aortic valve area defined as an initial aortic valve area of ≤ 1.0 cm2 or aortic valve area index < 0.6 cm2/m2, and
- Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram (or dobutamine stress echocardiogram, if subject has a left ventricular ejection fraction (LVEF) < 55%).
- The Medtronic Transcatheter Aortic Valve Replacement (TAVR) in Low-Risk Patients trial is designed to demonstrate the safety and effectiveness of the valve in low-risk patients. Previous research in high-risk patients showed TAVR with CoreValve to be superior to open heart surgery. Patients may qualify to take part in this prospective, randomized trial between traditional open heart surgery and TAVR if they are:
- Diagnosed with severe aortic stenosis
- Are at low risk for heart surgery
- Are 50+ years of age and in good health
Both studies use the Medtronic CoreValve Evolut™ R system. The valve recently became available in additional sizes, enabling a better fit for a broader patient population
The techniques associated with these trials involve the use of special catheters to guide prosthetic valves through the leg vessels to the heart. The minimally invasive approach is anticipated to offer benefits including:
- Reduced length of stay following the procedure
- Immediately improved breathing not hampered by incisional puncture sites in the groin area (in contrast to the painful chest incisions of open heart surgery)
- Faster, better mobility
- Discharge to home – as opposed to a rehabilitation or nursing care facility – and improved quality of life
Such trials offer less-invasive options for patients with a life-threatening diagnosis.
We are actively recruiting participants for both trials. To learn more, contact research nurse coordinator Tilitha Shawgo, RN, MS, at 913-588-9720 or email@example.com.