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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