Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study
NCT ID: NCT03000270
Last Updated: 2019-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2017-04-11
2018-08-16
Brief Summary
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Detailed Description
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Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prolonged unloading prior to PPCI
Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention
Impella unloading prior to PPCI
Impella unloading prior to PPCI
Immediate unloading prior to PPCI
Activation of Impella CP immediately prior to primary percutaneous coronary intervention
Impella unloading prior to PPCI
Impella unloading prior to PPCI
Interventions
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Impella unloading prior to PPCI
Impella unloading prior to PPCI
Eligibility Criteria
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Inclusion Criteria
* First myocardial infarction
* Acute anterior STEMI with ≥ 2 mm in 2 or more contiguous anterior leads or≥ 4 mm total ST-segment deviation sum in the anterior leads
* Signed Informed Consent
Exclusion Criteria
* Inferior STEMI or suspected right ventricular failure
* Suspected or known pregnancy
* Suspected active infection
* History or known hepatic insufficiency prior to catheterization
* On dialysis therapy
* Known contraindication to:
* Undergoing MRI or use of gadolinium
* Heparin, pork, pork products or contrast media
* Receiving a drug-eluting stent
* Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device
21 Years
80 Years
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Responsible Party
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Locations
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Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Wellstar/Kennestone Hospital
Marietta, Georgia, United States
Detroit Medical Center
Detroit, Illinois, United States
Advocate Edward Hospital
Oakbrook Terrace, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
ABIOMED, Inc.
Danvers, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum
Grand Rapids, Michigan, United States
Hackensack Medical Center
Hackensack, New Jersey, United States
University of Buffalo Hospital
Buffalo, New York, United States
Northwell Health
Manhasset, New York, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Greenville Health System
Greenville, South Carolina, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Countries
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References
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Kapur NK, Alkhouli MA, DeMartini TJ, Faraz H, George ZH, Goodwin MJ, Hernandez-Montfort JA, Iyer VS, Josephy N, Kalra S, Kaki A, Karas RH, Kimmelstiel CD, Koenig GC, Lau E, Lotun K, Madder RD, Mannino SF, Meraj PM, Moreland JA, Moses JW, Kim RL, Schreiber TL, Udelson JE, Witzke C, Wohns DHW, O'Neill WW. Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction. Circulation. 2019 Jan 15;139(3):337-346. doi: 10.1161/CIRCULATIONAHA.118.038269.
Related Links
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Unloading the Left Ventricle Before Reperfusion in Patients With Anterior ST-Segment-Elevation Myocardial Infarction.
Other Identifiers
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DTU - Safety and Feasibility
Identifier Type: -
Identifier Source: org_study_id
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