Medical Devices

Public Meeting - International Consortium of Cardiovascular Registries, April 22, 2013

The Food and Drug Administration (FDA) announced a public meeting entitled “International Consortium of Cardiovascular Registries”.

The purpose of the meeting was to discuss the development of an international consortium of cardiovascular registries with a broad array of interested stakeholders. The initial pilot phase of this effort was for developing relations and analysis strategies for transcatheter cardiac valve registries, with the understanding that these efforts would be expended to additional cardiovascular devices in the future.

Date, Time and Location:

This meeting was held April 22, 2013, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

The meeting was available via webcast.

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Time Subject
7:00 Registration Opens
7:15 Transportation from Hotel
8:00-8:05 Welcome and Introductions
FDA Presentations
8:05-8:15 FDA Vision and Interest in Consortia of Registries
8:15-8:25 Potential Role of International Registry Data in Permarket Decision Making
8:25-8:35 Worldwide Post-Market Data and ICCR-- the Role of MDEpiNet
8:35-8:40 Question and Answer Session
8:40-9:10 ICOR: A Distributed System of Registried with Data Controlled by Data Owners and Research Studies Questions and Answers
9:10-9:20 Question and Answers Session
Session I: Goals of International Registries and the Potential to Advance Collaborative Work Worldwide
9:20-9:35 The German Aortic Registry (GARY)
9:50-10:05 US STS/ACC TVT Registry
10:05-10:20 Question and Answer Session
10:20-10:30 Break
Session II: Goals of International Registries and the Potential to Advance Collaborative Work Worldwide
10:30-10:40 First Canadian Registry
10:50-11:05 English Registry

Dutch Registry and European Efforts Presentation 1
Dutch Registry and European Efforts Presentation 2 

11:20-11:35 Question and Answer Session
11:35-12:20 Working Lunch
12:20-1:35 Panel Discussion: How Registries Can Benefit from the International Consortium of TVT Registries
Analytic Methods and Specific Implant Safety and Effectiveness Outcome Reports
1:35-2:15 30 Day Outcomes Presentation 1
30 Day Outcomes Presentation 2
2:15-2:35 Longer Term Outcomes
2:35-2:45 Risk Model Needs: The Comprehensive vs Pragmatic Approach
2:45-2:55 Functioning and Quality of Life Data: What is Achievable?
2:55-3:20 Discussion
3:20-3:50 Next Steps
3:50 Adjourn Meeting

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An archived webcast for this event is available.

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Registration to Attend the Meeting:

Registration is closed as of April 11, 2013.

Onsite registration was available beginning at 7:00 a.m. on April 22.

There was no fee to register for the Meeting and registration was on a first-come, first-served basis. Early registration was recommended because seating is limited.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142,

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Contact Us

For questions regarding meeting content please contact:

Benjamin Eloff
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue,
Bldg. 66, Rm. 4210
Silver Spring, MD 20993
Phone: 301-796-8528

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Page Last Updated: 07/10/2014
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