CARDIOGENIC SHOCK: PRIME TIME FOR LARGE TRIALS?
Last update: April 4
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Last update: April 4 ✍️
A first draft preliminary program is now out.
The sessions and speakers and below are not confirmed and subject to change.
Thursday, June 8, 2023
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Arrival to the Embassy of France
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Alexandre Mebazaa (Paris, FRA) on behalf of the scientific committee
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Moderated by Susanna Price (London, GBR) & Hannah Schaubroeck (Ghent, BEL)
8:40 AM - 8:50 AM Standardized definition for research from Shock Academy Research Consortium Mitchell Krucoff (Durham, USA)
8:50 AM - 9:00 AM Update on shock phenotyping Jacob Jentzer (Rochester, USA)
9:00 AM - 9:10 AM Trial design in Refractory CS: what is special? Mattia Arrigo (Zurich, SUI)
9:10 AM - 9:20 AM Informed consent in CS clinical trials in the United States Robert Mentz (Durham, USA)
9:20 AM - 9:30 AM Informed consent in CS clinical trials in Europe Janine Pöss (Leipzig, GER)
9:30 AM - 9:40 AM ECLS Shock ended; what we learnt: on trial design Holger Thiele (Leipzig, GER)
9:40 AM - 9:50 AM ECLS Shock ended; what we learnt: on trial conduction Uwe Zeymer (Ludwigshafen, GER)
9:50 AM - 10:20 AM Panel discussion with the above as well as FDA, EMA, PDMA and NIH representatives & more.
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Item description
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Moderated by Alessandro Sionis (Barcelona, ESP) & Erin Bohula (Boston, USA)
10:40 AM - 10:45 AM COCCA Armand Mekontso Dessap (Paris, FRA)
10:45 AM - 10:50 AM DanGer shock Jacob Møller (Odense, DEN)
10:50 AM - 10:55 AM Hypo-ECMO Bruno Levy (Nancy, FRA)
10:55 AM - 11:00 AM ECMO-IABP Pascal Leprince (Paris, FRA)
11:00 AM - 11:05 AM Recover IV: what makes the design special Navin Kapur (Boston, USA)
11:05 AM - 11:10 AM PAC-CS trial TBC
11:10 AM - 11:15 AM Iso-Shock Mir Babar Basir (Detroit, USA)
11:15 AM - 11:20 AM IV-cangrelor STEMI schock William O'Neill (Detroit, USA)
11:20 AM - 12:00 PM Panel discussion with the above as well as FDA, EMA, PDMA and NIH representatives & more.
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Moderated by Alessandro Sionis (Barcelona, ESP) & Erin Bohula (Boston, USA)
12:00 PM - 12:10 PM DOREMI 2 Benjamin Hibbert (Ottawa, CAN)
12:10 PM - 12:20 PM Biotherapies Mahir Karakas (Hamburg, GER)
12:20 PM - 12:40 PM Panel discussion with the above as well as FDA, EMA, PDMA and NIH representatives & more.
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Moderated by Mitchell Krucoff (Durham, USA), Pascal Leprince (Paris, FRA) & Stuart Spencer (London, GBR)
3:30 PM - 3:40 PM Investigator US perspective Navin Kapur (Boston, USA)
3:40 PM - 3:50 PM Investigator Europe perspective (EU MDR) Holger Thiele (Leipzig, GER)
3:50 PM - 4:00 PM Investigator Japan perspective Naoki Sato (JPN)
4:00 PM - 4:07 PM Industry perspective Karine Bourgeois (4TEEN, GER)
4:07 PM - 3:14 PM Industry perspective TBD (Abbott)
4:14 PM - 4:21 PM Industry perspective Chuck Simonton (Abiomed, USA)
4:21 PM - 4:28 PM Industry perspective Andres Beiras (Getinge, GER)
4:28 PM - 4:35 PM Industry perspective MCRA (TBD)
4:35 PM - 4:45 PM FDA perspective
4:45 PM - 4:55 PM EMA perspective
4:55 PM - 5:05 PM PDMA perspective
5:05 PM - 5:15 PM Payer’s perspective
5:15 PM - 5:25 PM Patient’s perspective Rhonda Monroe (Charlotte, USA)
5:25 PM - 6:30 PM Panel discussion with the above as well as NIH representative & more.
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Item description
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Item description
8:00 AM - 8:30 AM Registration and welcome coffee
8:30 AM - 8:40 AM Welcome introduction Alexandre Mebazaa (Paris, FRA) on behalf of the scientific committee
Session 1: Cardiogenic Shock: latest news of 2023
Moderated by Susanna Price (London, GBR) & Hannah Schaubroeck (Ghent, BEL)
8:40 AM - 8:50 AM Standardized definition for research from Shock Academy Research Consortium Mitchell Krucoff (Durham, USA)
8:50 AM - 9:00 AM Update on shock phenotyping Jacob Jentzer (Rochester, USA)
9:00 AM - 9:10 AM Trial design in Refractory CS: what is special? Mattia Arrigo (Zurich, SUI)
9:10 AM - 9:20 AM Informed consent in CS clinical trials in the United States Robert Mentz (Durham, USA)
9:20 AM - 9:30 AM Informed consent in CS clinical trials in Europe Janine Pöss (Leipzig, GER)
9:30 AM - 9:40 AM ECLS Shock ended; what we learnt: on trial design Holger Thiele (Leipzig, GER)
9:40 AM - 9:50 AM ECLS Shock ended; what we learnt: on trial conduction Uwe Zeymer (Ludwigshafen, GER)
9:50 AM - 10:20 AM Panel discussion with the above as well as FDA, EMA, PDMA and NIH representatives & more.
10:20 AM - 10:40 AM Coffee break
Session 2 part A: Ongoing trials: an uneventful journey?
Moderated by Alessandro Sionis (Barcelona, ESP) & Erin Bohula (Boston, USA)
10:40 AM - 10:45 AM COCCA Armand Mekontso Dessap (Paris, FRA)
10:45 AM - 10:50 AM DanGer shock Jacob Møller (Odense, DEN)
10:50 AM - 10:55 AM Hypo-ECMO Bruno Levy (Nancy, FRA)
10:55 AM - 11:00 AM ECMO-IABP Pascal Leprince (Paris, FRA)
11:00 AM - 11:05 AM Recover IV: what makes the design special Navin Kapur (Boston, USA)
11:05 AM - 11:10 AM PAC-CS trial TBC
11:10 AM - 11:15 AM Iso-Shock Mir Babar Basir (Detroit, USA)
11:15 AM - 11:20 AM IV-cangrelor STEMI schock William O'Neill (Detroit, USA)
11:20 AM - 12:00 PM Panel discussion with the above as well as FDA, EMA, PDMA and NIH representatives & more.
Session 2 part B: IV therapies are still mandatory
Moderated by Alessandro Sionis (Barcelona, ESP) & Erin Bohula (Boston, USA)
12:00 PM - 12:10 PM DOREMI 2 Benjamin Hibbert (Ottawa, CAN)
12:10 PM - 12:20 PM Biotherapies Mahir Karakas (Hamburg, GER)
12:20 PM - 12:40 PM Panel discussion with the above as well as FDA, EMA, PDMA and NIH representatives & more.
12:40 PM - 1:30 PM Lunch break
Session 3: Registry-supported pivotal trial: ready for prime-time
Moderated by Marc Samsky (New Haven, USA) & Janine Pöss (Leipzig, GER)
1:30 PM - 1:40 PM Good start of AHA shock survey David Morrow (Boston, USA)
1:40 PM - 1:50 PM Global survey is needed Nadia Aissaoui (Paris, FRA)
1:50 PM - 2:00 PM Device and surgery Pascal Leprince (Paris, FRA)
2:00 PM - 2:10 PM Connecting long-term registry to Index hospitalization data Robert Yeh (Boston, USA)
2:10 PM - 2:20 PM Bleeding events at vascular access with MCS Eric Vang (Medtronic, USA)
2:20 PM - 2:25 PM FDA perspective Bram Zuckerman & Mauro Moscucci (FDA, USA)
2:25 PM - 2:30 PM EMA perspective EMA
2:30 PM - 2:35 PM PDMA perspective PDMA
2:35 PM - 2:40 PM NIH perspective NIH
2:40 PM - 3:10 PM Panel discussion with the above & more.
3:10 PM - 3:40 PM Coffee break
Session 4: Roundtable Discussion
Are regulator needs the same across the globe?
Moderated by Mitchell Krucoff (Durham, USA), Pascal Leprince (Paris, FRA) & Stuart Spencer (London, GBR)
3:30 PM - 3:40 PM Investigator US perspective Navin Kapur (Boston, USA)
3:40 PM - 3:50 PM Investigator Europe perspective (EU MDR) Holger Thiele (Leipzig, GER)
3:50 PM - 4:00 PM Investigator Japan perspective Naoki Sato (JPN)
4:00 PM - 4:07 PM Industry perspective Karine Bourgeois (4TEEN, GER)
4:07 PM - 3:14 PM Industry perspective TBD (Abbott)
4:14 PM - 4:21 PM Industry perspective Chuck Simonton (Abiomed, USA)
4:21 PM - 4:28 PM Industry perspective Andres Beiras (Getinge, GER)
4:28 PM - 4:35 PM Industry perspective MCRA (TBD)
4:35 PM - 4:45 PM FDA perspective
4:45 PM - 4:55 PM EMA perspective
4:55 PM - 5:05 PM PDMA perspective
5:05 PM - 5:15 PM Payer’s perspective
5:15 PM - 5:25 PM Patient’s perspective Rhonda Monroe (Charlotte, USA)
5:25 PM - 6:30 PM Panel discussion with the above as well as NIH representative & more.
6:30 PM Adjourn
6:30 PM - 8:00 PM Cocktail & dinner in the Embassy of France, Washington D.C.
Please find below the programs of the past editions: