EP PASSION CRN - MDEpiNet.orgmdepinet.org/wp-content/uploads/EP-PASSION-CRN.pdf · 2019-12-18 ·...
Transcript of EP PASSION CRN - MDEpiNet.orgmdepinet.org/wp-content/uploads/EP-PASSION-CRN.pdf · 2019-12-18 ·...
Electrophysiology Predictable and Sustainable Implementation of National Registries: EP PASSION
LiWang,PhD,MBA,MS,DanielCanos,PhD,MPH,HetalPatel,MS,JessicaPaulsen,BS,KimberlySelzman,MD,BenjaminEloff,PhD,Danica Marinac-Dabic, MD,PhD,MMSc,FISPE.
OfficeofSurveillance and Biometrics &Office ofDevice Evaluation,CenterforDevices and RadiologicalHealthU.S.Foodand Drug Administration, SilverSpring,MD.20903
TheRegulatoryGapTraditionalPost-ApprovalInefficiencies• Stand-AloneStudy• PaceandEnrollmentDifficulty• ProlongedCompletionTime• NextGenerationonmarketbefore“LessonsLearned”TraditionalPost-MarketStudyCost• ~$10millionintraditionalPASstudies
• Potential40-60%savingswithregistrybasedsurveillance
EPPASSIONObjectivesEPPASSIONisfocusedonimplantablecardioverterdefibrillatorsystemleadsandpulsegeneratorsandcardiacresynchronizationtherapyleftheartleads.ARWE-basedapproachcanstreamlinepost-approvalstudiesby:
• ReducingCost• Reducetimetoenrollmentcompletion• Reducelosstofollow-up• Providetimelyanswerstopost-marketquestions
Objective1:• Transitionlong-termdirectionpatientfollow-upassessmentincurrentpost-
approvalstudies(PAS)towardsarealworldevidenceapproach(RWE).Objective2:• Developsustainablemechanismtocollectlong-termchronicperformanceof
newandsubstantiallymodifiedpacinganddefibrillationleads.
EPPASSIONComponents
Phase II: ID & Assess
Phase III: Develop New/Modify
Phase IV: Develop Linked Approach
EPPASSIONPhasedApproachEPPASSIONPost-ApprovalStudyTransition
ExtantRegistry/EHR
Claims RemoteMonitoring
Implant&Periprocedural
DataAnnual
Follow-Up
AnnualFollow-Up
TraditionalPAS
TransitionofOngoingPAS
~10Years
<10Years
NovelRWEPAS<10Years
EPPASSIONInfluenceTheshifttowardsRWEintheEPfieldhasalreadybegun….• FDArecentlyapprovedtheBostonScientificS-ICDPost-ApprovalStudy
withnopre-marketdata.Thepowered,hypothesis-drivenstudyincorporatestheACCNCDRregistry,BostonScientific’sLATITUDENXTPatientManagementSystem,CMS/Truven claims,andtheNationalDeathIndex.
EPPASSIONPartners
EPPASSIONTimeline