• Challenges of Enrolling into Clinical Trials During Commercialization of TAVR

    Thomas Armitage, M.D. Medtronic Structural Heart 25 February 2013 Thomas Armitage is an employee of Medtronic, Inc. and owns Medtronic stock Background on TAVI Clinical Trial Design Evolution The evolution of PHVs will likely see three distinct eras of clinical trials- Era 1- No commercially available device - Studies consist of randomization to SAVR or OMM Era 2- Studies may involve randomization to a commercially available device (assumes similar populations targeted) Era 3- Long-term clinical data are available leading to the development of objective performance criteria Quantity- Are there enough patients? Raw numbers Study Competition- Multiple ongoing studies Patient Self Interest- the patients want TAVI Risk Characterization- Are the patients the right patients? Independent of commercial TAVI, it’s hard to find patients that meet all inclusion / exclusion criteria Patient prevalence pools may have been depleted by previous studies Sites are not sitting with tens of severe aortic stenosis patients – these people are being treated High volume cardiovascular programs already involved in studies May not want to participate in two studies You may need to share patients with another company / study Does the site have the research infrastructure to keep pace Patients are informed/empowered Patients know the results of TAVI Patients fear surgery and will overlook shortcomings of TAVI to avoid surgery Establishing Risk Patient risk assessment is qualitative, supported by the STS score Patients will seek an assessment that qualifies them for TAVI Clinicians want to serve their patients and may, inadvertently, bias their risk assessments to qualify their patients for TAVI * Comorbidities Concomitant Valve Procedures Concomitant CABG Other Clinical Exclusions Patient/Physician Preference Minor Economic Exclusion Surgical AVR Surgical AVR TAVI Medical Management TAVI Medical Management Surgical AVR (1) STS Adult Cardiac Database. 2010 Harvest, Isolated AVR (2) Roberts et al. Am J Cardiol 2012; 109(11)-1632-6 (3) Buchner et al. Heart 2010; 96-1233-1240 (4) Roberts et al. Circulation. 2005; 111-920–925 (5) Davies et al. Heart 1996; 75- 174-178 (6) Bach et al. JACC 2007; 50(20)-2018-2019 (7) Iung et al. European Heart Journal. 2003; 24- 1231-1243 (8) Pellikka et al. Circulation. 2005; 111-3290-3295 (9) Charlson et al. Journal of Heart Valve Disease. 2006; 15-312-321 (10) Nkomo et al. Lancet. 2006; 368-1005-1011 (11) Lindroos et al. JACC. 1993; 21(5)- 1220-1225 (12) Vahanian et al. EHJ 2010; 31-416-423 Good luck – enrolling your trial is not going to be easy Look for high volume institutions that can perform your trial Traditional high volume sites who may have completed another company’s trial Diamonds in the rough; sites that have been overlooked with good volumes and a desire to prove their research capabilities

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