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Business Structure Evaluation Process Updates

We're currently conducting an evaluation of Lee Health's business structure. Explore all available documents and dive deeper into the process by learning more here. Lee Health’s Board of Directors invites you to a public hearing, set for Thursday, April 25th in the Community Room at Gulf Coast Medical Center, to discuss the ongoing evaluation of converting the health system to a community-focused nonprofit structure. Learn more details here.

Shipley Cardiothoracic Research

The Research Department of Shipley Cardiothoracic Center has the goal of bringing national and international research opportunities to our SWFL community. Our current sponsored studies involve structural heart issues, noninvasive and minimally invasive cardiac procedures, and sternal bone closure after cardiac surgery.

Shipley Research also provides support for others with research interests, including PHD students, interns, and physician and nursing staff.  

Early in the COVID crisis, Tthe Shipley Research Coordinators, PA, RN TAVR Navigator and Community Outreach Coordinator supported Dr. Douglas Brust in participating in the Mayo Clinic COVID-19 Convalescent Plasma research trial. 

This trial lead to the FDA authorizing convalescent plasma to treat patients with COVID 19.

Currently Enrolling Research Studies: 

Transcatheter Mitral Valve Replacement with the Medtronic TMVR System in Patients with Severe Symptomatic Mitral Regurgitation- Apollo Trial (Medtronic)

Principal Investigator: Dr. Michael DeFrain 

Co-Principal Investigator: Dr. Murali Muppala       

Sub-Investigators: Dr. Paul DiGiogio, Dr. Steven Priest and Dr. Daniel Krauss 

Summary: Evaluate the safety and effectiveness of the Medtronic TMVR system, a transcatheter mitral valve replacement placement system, compared to traditional surgical mitral valve replacement. Outcomes measured will be all cause mortality, stroke, re-operation and cardiovascular hospitalization at one year. 

 SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial)

Principal Investigator: Dr. Michael DeFrain    

Co-Principal Investigator: Dr. Murali Muppala 

Sub-Investigators: Dr. Steven Priest and Dr. Scott Allen  

Summary: Generate clinical evidence on valve safety and performance of self-expanding versus balloon-expandable transcatheter aortic valve placement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Outcome measures will be mortality, stroke, valve or heart failure related hospitalizations, and valve dysfunction at one year.

Randomized, Single Blinded Pilot Study of Stainless Steel Wire Cerclage versus FiberTape® Cerclage

Principal Investigator: Dr. Paul DiGiorgi

Co-Principal Investigator: Dr. Michael DeFrain

Summary: Evaluate the progression of sternal bone healing in subjects who underwent sternal closure with FiberTape braided suture versus stainless steel wire. A CT scan is done at three months to assess bone healing. Postoperative pain and complication rates will also be compared between the two groups.

Research Studies in Long Term Follow-Up: Closed to Enrollment 

Transcatheter Aortic Valve Replacement (TAVR) in Patients with Severe Aortic Valve Stenosis and Low Predicted Risk of Mortality with Surgical Aortic Valve Replacement (Medtronic) 

Principal Investigator: Dr. Michael DeFrain 

Co-Principal Investigator: Dr. Murali Muppala 

Sub-Investigators: Dr. Steven Priest and Dr. Scott Allen    

Summary: Evaluate the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years in order to compare for non-inferiority to surgical aortic valve replacement in the treatment of low mortality risk patients. This trial closed to enrollment in August 2018. Participants in this study will be in follow-up until 2028. 

Transcatheter Aortic Valve Replacement (TAVR) in Patients with Severe Aortic Valve Stenosis and Low Predicted Risk of Mortality with Surgical Aortic Valve Replacement- Continued Access (Medtronic) 

Principal Investigator: Dr. Michael DeFrain 

Co-Principal Investigator: Dr. Murali Muppala  

Sub-Investigators: Dr. Steven Priest and Dr. Scott Allen    

Summary: This trial opened in November 2018 to allow research sites who participated in the original trial to continue to offer TAVR to low surgical mortality risk patients while the FDA considered approval of the procedure in this patient population. The FDA approved the Medtronic TAVR system for use in the low surgical mortality risk population on August 16, 2019. Participants in this study will be in follow-up through 2020. 

Transcatheter Aortic Valve Replacement (TAVR) in Patients with Severe BICUSPID Aortic Valve Stenosis and Low Predicted Risk of Mortality with Surgical Aortic Valve Replacement (Medtronic) 

Principal Investigator: Dr. Michael DeFrain 

Co-Principal Investigator: Dr. Murali Muppala 

Sub-Investigators: Dr. Steven Priest and Dr. Scott Allen    

Summary: Evaluate the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at 30 days in patients with bicuspid aortic valve anatomy and severe aortic stenosis who are at low mortality risk for surgical aortic valve replacement. The original low risk TAVR study excluded bicuspid anatomy. This study closed for enrollment in October 2019. Participants in this study will be in follow-up until 2029. 

In 2020, results from these TAVR studies led the FDA to approve the TAVR procedure to treat all surgical risk levels of patients with severe, symptomatic aortic stenosis. Long term follow-up continues to provide data on outcomes through 10 years post-procedure.

Hybrid Coronary Revascularization Trial (NHLBI) 

Principal Investigators: Dr. Paul DiGiorgi and Dr. Murali Muppala   

Sub-Investigators: Dr. Orlando Escarcega and Dr. Subhash Kshetrapal  

Summary: To determine the best treatment option for patients with multi-vessel coronary artery disease. The treatment options compared in this study were percutaneous coronary intervention (PCI) only; and hybrid coronary revascularization, consisting of surgical revascularization of the LAD with PCI of the other vessels. This study closed for enrollment in March 2019. Participants in this study will be in follow-up through 2020.

Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (AKI) following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery (Astellas Pharma Inc.)

Principal Investigator: Dr. Michael DeFrain    

Sub-Investigators: Dr. Randall Buss, Dr. Paul DiGiorgi and Dr. Brian Hummel 

Summary: This is a double-blind, placebo-controlled, randomized study to evaluate the effectiveness of post surgery treatment with ASP1128 in subjects at moderate or high risk for AKI following CABG and/or valve surgery in which cardiopulmonary bypass is used.