INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery

Part of paid clinical trials in Tampa, Florida.

Sponsor
Abiomed Inc.
Study ID
NCT06965504
Status
Not Yet Recruiting

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Conditions

  • Cardiogenic Shock
  • Heart Failure
  • Reduced Ejection Fraction Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Impella 5.5 SmartAssist — DEVICE
    The intervention is Impella 5.5 with SmartAssist® support combined with protocolized guideline directed medical therapy (GDMT) and HF-CS best practices.

Study Details

The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.

Key Dates

First listed
May 11, 2025
Start date
Sep 1, 2026
Status verified
Sep 2026
Primary completion
Dec 1, 2028
Completion
Jun 1, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single arm study
    This is a single arm study.

Primary Outcome Measure

Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation) [ Time Frame: Timeframe: 180-days post-enrollment ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33606
Courtney Nicholas, BS RN, CCRP, CVRN-BC
[email protected]
813-844-4914
Debbie Rinde-Hoffman, MD, FACC, FACP, FHFSA (PRINCIPAL_INVESTIGATOR)
Ascension St. VincentIndianapolisIndiana46260
Jennifer Brown
[email protected]
317-338-6439
Sunit-Preet Chaudhry, MD, FACC (PRINCIPAL_INVESTIGATOR)
Abbott NorthwesternMinneapolisMinnesota555407
Juilanne Feola
[email protected]
612-863-6066
Kasia Hryniewicz, MD (PRINCIPAL_INVESTIGATOR)
Barnes JewishSt LouisMissouri63110
Jean Flanagan
[email protected]
314-454-7451
Justin Vader, MD, MPHS (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Manuel Castillo
[email protected]
551-996-2136
Kanika Mody, MD (PRINCIPAL_INVESTIGATOR)
Rutgers-Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901
Manisha Bajpai, MD
[email protected]
732-258-3649
Maya Guglin, MD, PhD (PRINCIPAL_INVESTIGATOR)
Atrium HealthCharlotteNorth Carolina28204
Haley Bonilla
[email protected]
704-468-3193
Priyesh Patel, M.D. (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Elyse Wilson
[email protected]
(919) 681-8879
Adam DeVore, MD, MHS, FHFSA, FAHA, FACC (PRINCIPAL_INVESTIGATOR)
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Karen Blinson Research Coordinator
[email protected]
336-716-5706
Olivia Gilbert, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104
Alyson Brown
[email protected]
215-662-2128
Joyce Wald, DO, FACC (PRINCIPAL_INVESTIGATOR)
Allegheny General HospitalPittsburghPennsylvania15212
Laurie Machen
[email protected]
412-359-6181
Matthew Lander, MD (PRINCIPAL_INVESTIGATOR)
UPMC PresbyterianPittsburghPennsylvania15213
Traci Mc Gaha
[email protected]
412-692-2769
Sideris Facaros, MD (PRINCIPAL_INVESTIGATOR)
Centennial Medical CenterNashvilleTennessee32703
Kristen Kuhn
[email protected]
615.982.0640
Thomas McRae, MD, FACC (PRINCIPAL_INVESTIGATOR)
Zachary J II'Giovine, MD, FACC (PRINCIPAL_INVESTIGATOR)
Medical City Heart Hospital DallasDallasTexas75243
Lauren Horton
[email protected]
469-887-3274
Song Li, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132
Ashley Elmer
[email protected]
801.585.6775
Stavros Drakos, MD (PRINCIPAL_INVESTIGATOR)

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