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TRANSCATHETER HEART VALVE THERAPIES TRIALS

Chairpersons: Robert Bonow (Chicago, USA), Ileana Pina (New York, USA)
3.30 pm – 7.30 pm
 Could THV device approval follow a pathway analogous to that of surgical heart
valves by incorporating OPC? Would this be more appropriate only for approval of
new-generation THVs in high- and extreme-risk patient populations?
 Should approval of THV devices for low- and intermediate-risk patients or for new
indications be based on data from randomized, clinical trials?
 How contemporary registries may be useful as a platform for regulatory reform of
cardiovascular devices, for generating data to serve as a comparator arm for future
trials and to establish objective performance criteria? To perform comprehensive,
reliable, and timely post-marketing safety surveillance

 Surgical heart valves can be approved on the basis of objective performance criteria
(OPC). In contrast, stricter criteria for transcatheter heart valve (THV) approval,
including randomized, clinical trials. FDA has recently approved new-generation
THVs based on single-arm studies.
Trial design and endpoint definitions for trans catheter valve trials
Pieter Kappetein (Rotterdam, NED)
When and how to apply to trans catheter valve trials?
Jeffrey Borer (New York, USA)
Industry perspective:
Martyn Thomas (Edwards, USA)
Statistical considerations beyond objective performance criteria.in trans catheter
valve trials?
Mike Boulware (Medtronic, USA)
Insights from Transcatheter Valve Replacement (TAVR) Registries
Ileana Pina (New York, USA)
Registries as a platform for regulatory approval. Are we there yet? What actions
are needed to get there?
Roxana Mehran (New York, USA)
New valve designs, and how large a change in a device requires further clinical
testing?
Danny Dvir (Seattle, USA)
Mitral valve replacement trials and repair
Jeffrey Popma (Boston, USA)

Upstream TAVI in the less sick: when to replace the valve?
Pascal Leprince (Paris, FRA)
NHLBI Perspective.
Marissa Miller (NHLBI, USA)
Industry Perspective.
Patrick Verta (Edwards, USA)
Regulatory Perspective.
John Laschinger (FDA, USA); Bernard Vasseur (FDA, USA), Alan Fraser (Cardiff, GBR)
Payers viewpoint: How far upstream will TAVI be reimbursable? Based on which
evidence?
Tamara Syrek Jensen (CMS, USA); Harindra Wijeysundera (Canadian Agency for Drugs and
Technologies in Health, CAN)
Thrombosis trials in TAVR patients
· Thrombus apposition and valve mobility/durability in TAVR. The rationale
for OAC.
Rajendra Makkar (Los Angeles, USA)
· Industry perspective
Martin Unverdorben (Daiichi Sankyo, USA)
· Regulatory Perspective. Which study designs maybe accepted to obtain
approval of an antithrombotic regimen?
Karen Hicks (FDA, USA)
Patient viewpoint : Stefan Teunis (Oldenzaal, NED)

The Forum: Moderated discussion with the audience
How to tackle the ever-evolving technologies?
How to optimize anti-bleeding strategies?
Chairpersons: Robert Bonow (Chicago, USA), Ileana Pina (New York, USA)
Panelists: Robert Bonow (Chicago, USA), Jeffrey Borer (New York, USA), Mike
Boulware (Medtronic, USA), Danny Dvir (Seattle, USA), Alan Fraser (Cardiff, GBR),
Karen Hicks (FDA, USA), Pieter Kappetein (Rotterdam, NED), John Laschinger (FDA,
USA), Pascal Leprince (Paris, FRA), Rajendra Makkar (Los Angeles, USA), Roxana
Mehran (New York, USA), Marissa Miller (NHLBI, USA), Ileana Pina (New York, USA),
Jeffrey Popma (Boston, USA), Dan Schaber (Medtronic, USA), Tamara Syrek Jensen
(CMS, USA), Stefan Teunis (Oldenzaal, NED), Martyn Thomas (Edwards, USA), Martin
Unverdorben (Daiichi Sankyo, USA), Bernard Vasseur (FDA, USA), Patrick Verta
(Edwards, USA), Harindra Wijeysundera (Canadian Agency for Drugs and Technologies
in Health, CAN),