PUMPKIN BACKGROUND UPDATE ON PUMPKIN TRIAL
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Update on PumpKIN Trial Max B. Mitchell, MD The Children’s Hospital Heart Institute Professor of Surgery University of Colorado Denver Health Science Center PumpKIN Background • 2002: NHLBI issued a Broad Agency Announcement (BAA) entitled “Pediatric Pediatric Circulatory Support Program” (PCSP) • Key Technical requirements of PCSP: – Children 2-25 kg – Durability of 6 months support – Functioning within 1 hour – Minimal prime volume – Appropriate cannulation strategies – Minimal blood product exposure – Minimize risks of serious adverse events
PCSP: At first there were 5 Pulsatile Pediatric VADs Penn State University Awarded 2004 PediPump Cleveland Clinic Foundation $22 4 million $22.4 illi Infant Jarvik 2000 Jarvik Heart Inc.* Pediatric Cardiopulmonary Assist System PediaFlow (pCAS) Ension, Inc. Univ Pittsburgh* PCSP begets PumpKIN • 2004-2009: Engineering & device development phase of 5 PCSP devices • Oct 2008: NHLBI issued RFP called the Pumps for Kids, Infants, and Neonates (PumpKIN) Program • Purposes: – Support the pre-clinical work required for contractors to obtain IDEs from the FDA – Implement IDE clinical trials leading to FDA device approval(s) under HDE guidelines
PumpKIN: then there were 4 • Jan 2010: NHLBI issued 4 awards: – 3 of the PCSP Contractors: • PediaFlow: University of Pittsburgh • Infant Jarvik 2000: Jarvik Heart Corp • pCAS: Ension, Inc – 4th award went to new Contractor: • PediPL: Pedi Pump-Lung, Pump-Lung University of Maryland • 2 axial flow VADS, 2 ACE systems • Awards totaled $23.6 million PumpKIN Program • Dec 2010: NHLBI issued RFP for a Data andd Cli Clinical i l Coordinating C di ti C Center t (DCCC) tto manage the clinical phases of the PumpKIN program • April 2012: NERI (New England Research Institute, Inc.) awarded the DCCC contract • NERI’s award contract worth $18.8 million
Summer 2012 PediPL PediaFlow Univ Maryland Univ Pittsburgh Infant Jarvik 2000 pCAS Jarvik Heart, Inc. Ension, Inc. DCCC PumpKIN 2012 • June 2012: NERI contacted potential clinical sites to solicit interest and information regarding institutional support for PumpKIN • 4 devices (2 VADs, 2 ACE systems)
PumpKIN 2013: then there were 3 • Jan 2013: NERI provided an update to potential t ti l clinical li i l sites it att th the S Society i t off Thoracic Surgeons Annual Meeting – 3 devices, 2 prospective randomized trials: • Jarvik 2000 vs. Berlin Heart Excor control group • pCAS & PediPL vs. conventional ECMO control • PediaFlow absent from update documents PediaFlow VAD eliminated Aug 2012
PumpKIN 2013 • Feb 2013: clinical site applications distributed by NERI • Mar 2013: site applications submitted • June 2013: NERI announced selection of 22 sites PumpKIN Clinical Sites Site Surgical PI Cardiology PI A.I. duPont Hospital for Children Christian Pizarro, MD Michael McCullogh, MD Arkansas Children's Hospital Michiaki Imamura, MD, PhD Elizabeth Frazier, MD Boston Children's Hospital Francis Fynn-Thompson, MD Christina VanderPluym, MD Children's Healthcare of Atlanta Kirk Kanter, MD Shriprasad Deshpande, MD Children's Hospital Colorado Max Mitchell, MD Scott Auerbach, MD & Shannon Buckvold, MD Children's Hospital of Philadelphia (CHOP) William Gaynor, MD Joseph Rossano, MD Children's Hospital of Wisconsin James Tweddell, MD Nancy Ghanayem, MD Children's Medical Ctr, Dallas Kristine Guleserian, MD Aliessa Barnes, MD CHONY-Columbia University Medical Center Emile Bacha, MD Marc E. Richmond, MD, MS Cincinnati Children's Hospital David Morales, MD Angela Lorts, MD Duke University Hospital Andrew Lodge, MD Michael Carboni, MD Hospital for Sick Children, Toronto Glen Van Arsdell, MD Tilman Humpl, MD, PhD Lucile Packard Chidlren's Hospital, Stanford University Olaf Reinhartz, MD David Rosenthal, MD Monroe Carell Children Children's s Hospital Hospital, Vanderbilt University Bret Mettler, Mettler MD Debra Dodd, Dodd MD Nationwide Children's Hospital Patrick McConnell, MD Timothy Hoffman, MD Seattle Children's Hospital David M. McMullan, MD Sabrina Law, MD St. Louis Children's Hospital Wash U. St. Louis Pirooz Eghtesady, MD, PhD Charles Canter, MD Stollery Children's Hospital, Edmonton Ivan Rebeyka, MD Holger Buchholz, MD Charles Fraser, MD & Iki Adachi, Texas Children's Hospital MD Aamir Jeewa, MD University of Alabama, Birmingham James Kirklin, MD F. Bennett Pearce, MD University of Michigan C.S. Mot Children's Hospital Richard Ohye, MD Robert Gajarski, MD University of Minnesota Amplatz Children's Hospital James D. St. Louis, MD Rebecca K. Ameduri, MD
PumpKIN 2013: then there were 2 • June 2013 site announcement indicated th t P that PumpKIN KIN will ill iinvolve l 2ddevices, i 2 trials: • VAD: Jarvik 2000 vs. Berlin Heart Excor • ACE: PediPL vs. conventional ECMO • All sites will participate in each trial (VAD, & ACE) • Ension’s pCAS eliminated Ension pCAS eliminated • Additional Costs and Time needed for preclinical development • Ension determined they would not be able to meet the contracted IDE application timeline
Where does PumpKIN stand now? Nov 2013: and then there was 1 • L Lastt weekk Th Thoratec t withdrew ithd th the P PediPL diPL from f PumpKIN • Technical issues?
The last man standing Planned PumpKIN VAD Protocol PumpKIN (Infant Jarvik 2000) Prospective Trial Design Two-Arm Randomized to Control Berlin Heart EXCOR Patient Size ≤ 0.8 m2 Patient Weight > 4 Kg and < 15 Kg HF Diagnosis Severe 2 Vent Severe, Vent. HF Sample Size 44/group* Centers 22 Primary Probable Benefit Survival w/out new severe Endpoint NI at 180 days Primary Safety Endpoint SAE rate for 180 days
Latest PumpKIN Timeline IDE Applications IDE Approvals (Contingent on FDA Decision) 2013 2014 2015 2016 2017 2018 Phase I Phase II Phase III Clinical Cli i l Trials Ti l Protocol Development Data Analyses Clinical Site Prep Publications Training HDE Applications Summary of current PumpKIN status • NHLBI review of protocols complete • FDA Pre-IDE review of protocols complete • Clinical sites selected • DSMB Appointed • Site training planned (March 2014) • Devices and Timing of IDE(s) uncertain
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