Rachel Neubrander, PhD Division of Cardiovascular Devices

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Looking Forward: FDA Perspective on New Clinical Trial Designs for LAA Occluders Rachel Neubrander, PhD Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health (CDRH) rachel.neubrander@fda.hhs.gov CRT 2017 February 20, 2017

Disclosures No conflicts of interest to report. www.fda.gov

LAA Occlusion to Prevent Ischemic Stroke WATCHMAN approved March 2015 LAAO registry launched December 2015 CMS Coverage with Evidence Development finalized February 2016 Looking forward: Development of new devices Address other knowledge gaps www.fda.gov

New LAA Occlusion Devices: Framing Benefit – Risk in Pivotal Trials Is the LAA occlusion procedure associated with an acceptable rate of device and procedure-related complications? Does the LAA occlusion device provide adequate protection from ischemic stroke? In device vs. anticoagulation trials, is the avoidance of long-term AC following LAA occlusion associated with a reduced risk of major bleeding complications?

Potential Trial Designs New device: OAC eligible patients: Randomized controlled trial (RCT) of investigational device vs. approved device or investigational device vs. OAC (particularly NOACs) OAC unsuitable patients: RCT of investigational device vs. ASA/no treatment Iteration of approved device: Dependent on the design change(s) Consider alternative, least-burdensome trial design

OAC unsuitable patient population Individuals with absolute and important relative contraindications to anticoagulation Randomized trials needed to establish safety and effectiveness and define benefit-risk Single arm studies using performance goals (PGs) not adequate Ongoing ASAP-TOO trial adequately powered to address benefit-risk questions in this patient population

Current WATCHMAN US DFU includes: Safety and Effectiveness of Alternative Medication Regimens Post-LAA Occluder Implantation Current WATCHMAN US DFU includes: Warfarin + aspirin for at least 45 days Aspirin + clopidogrel through 6 months Alternative post-implantation regimens include: DAPT alone (no warfarin) NOACs Well designed and conducted prospective studies needed

Leveraging LAAO registry infrastructure Potential for more efficient utilization of resources Post-approval surveillance of safety and effectiveness outcomes Real world evidence Meeting data requirements of payers Embedding IDE studies within a registry New indications or clinical updates to labels for approved devices Approval of new devices Study designs Single-arm studies with historical controls Randomized controlled trial

Embedding an IDE in an Ongoing Registry The 8 A’s for a High Quality Study Agreement to participate: Informed consent Analysis: Study protocol, pre-specified event definitions, statistical analysis plan Accountability of study subjects: Minimize subject withdrawals and lost to follow-up Accumulation of data: Minimize missing information Accuracy of data collection and recording Adjudication of events Auditing and monitoring of study data Access to data by investigators, industry, FDA, CMS

Conclusions High quality data is needed to support marketing of new devices and to address knowledge gaps in field of LAA occlusion Opportunities to use registry infrastructure for pre- and post-market clinical studies Early interactions among FDA, sponsors, investigators, and CMS recommended to develop studies to support both marketing and coverage