Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Columbia University
- Enrollment
- 1,089
- Locations
- 7
- Primary Endpoint
- 1-year survival post mechanical circulatory assist device implant
Study Overview
Brief Summary
The purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (VAD) or 2) heart transplant. the study seeks to determine which patient populations benefit from heart transplant or ventricular assist device. This will allow to offer the state-of-the-art care to the patients in heart failure.
Detailed Description
Cardiogenic shock (CS) develops in the end stage of various etiologies of heart failure and continues to hold high mortality; ranging from 50 to 80%. Expert consensus recommends use of more powerful mechanical circulatory support device (MCSD) in this patient population; however, scientific evidence has been anecdotal relying on mostly single-center small case series and, more fundamentally, because there is no unified definition to grade the severity of the highly heterogeneous condition CS. Well-designed studies are warranted to precisely characterize the various "phenotypes" of CS as well as the role of MCSD in this condition with still excessive mortality.
This multicenter registry will be the first multicenter large-scale registry focused on mechanical circulatory support (MCS) therapy for CS. The fundamental goal of RESCUE is to advance the understanding and application of MCSD in order to improve the persistently dismal survival of patients with CS with the following intents:
- Elucidate current indication and outcomes of MCSD use in CS.
- Redefine CS with better description of this disease entity, which will allow better prediction of outcomes, selection of treatment strategy, and comparison and design of studies.
- Facilitate the refinement of patient selection to maximize outcomes with current and new device options.
- Improve and expedite new device clinical trials by providing historical control data.
- Develop consensus "best practice" guidelines to improve clinical management by reducing short and long-term complications of MCSD therapy.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients who receive any MCSD including Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO), surgical VAD, and percutaneous VAD, used to treat CS on or after 9/30/
- •Intraaortic balloon pumping (IABP) is not considered an MCSD in this Registry.
- •Adult patients who have signed informed consent. For patients who are too ill to give informed consent the health care proxy of the patient or next of kin will be approached for the informed consent.
Exclusion Criteria
- •patients younger than 18 years of age.
Outcomes
Primary Outcomes
1-year survival post mechanical circulatory assist device implant
Time Frame: 12 months
Secondary Outcomes
- 30-day survival post mechanical circulatory assist device implant(30 days)
- survival to discharge post mechanical circulatory assist device implant(until the enrolled patient is discharged. Expected to occur within 90 days of enrollment.)
- Number of adverse events during mechanical circulatory assist device support(up to 30-days of weaning from the device.)