Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study (DTU)

• ClinicalTrials.gov Identifier: NCT03000270
• Recruitment Status: Completed
• First Posted: December 22, 2016
• Last Update Posted: May 6, 2019
• Sponsor: Abiomed Inc.
• Information provided by (Responsible Party): Abiomed Inc.

Tracking Information

• First Submitted Date: December 12, 2016
• First Posted Date: December 22, 2016
• Last Update Posted Date: May 6, 2019
• Actual Study Start Date: April 11, 2017
• Actual Primary Completion Date: June 19, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 2, 2018)

• Infarct size at 30 Days [ Time Frame: 30 Days ]
  Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI
• MACCE at 30 Days [ Time Frame: 30 Days ]
  A composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days:

  • Cardiovascular mortality
  • Re-infarction
  • Stroke/TIA
  • Major vascular complication

Original Primary Outcome Measures (submitted: December 21, 2016)

Infarct size at 30 Days [ Time Frame: 30 Days ]

Assessment of Infarct size as a percent of left ventricular mass, evaluated using CMR, at 30 days post PPCI

Current Secondary Outcome Measures (submitted: May 2, 2019)

• Infarct Characteristics - LV mass [ Time Frame: 3 - 5 and 30 Days ]
  Using CMR at 3-5 & 30 days, assessement of Infarct size as a percent of LV mass
• Infarct Characteristics - area at risk [ Time Frame: 3 - 5 and 30 Days ]
  Using CMR at 3-5 & 30 days, assessment of Infarct size as a percent of area (myocardium) at risk,
• 30 Day Safety Endpoint Rates [ Time Frame: 30 Days ]
  Event rate for All-cause mortality, Cardiovascular mortality, Re-infarction, Stroke/TIA, Vascular complications, Worsening heart failure or hemodynamic compromise requiring inotropic or hemodynamic support post Impella explant, Repeat revascularization, Aortic valve injury or dysfunction, Renal failure, Hemolysis, Hematoma, Bleeding, Thrombocytopenia
• Infarct Characteristics microvascular obstruction [ Time Frame: 3-5 and 30 Days ]
  Using CMR at 3-5 & 30 days, measurement of percent of microvascular obstruction (%MVO)
• Left Ventricular Function- LV end systolic and diastolic volume index [ Time Frame: 3-5 and 30 Days ]
  Using CMR imaging post PCI: assessment of LV end systolic and diastolic volume index (LVESVi & LVEDVi)
• Left Ventricular Function - Ejection Fraction [ Time Frame: 3-5 and 30 Days ]
  Using CMR at 3-5 & 30 days post PCI: assessment of Ejection fraction (EF)

Original Secondary Outcome Measures (submitted: December 21, 2016)

• Efficacy: Infarct Size as a % of LV Mass [ Time Frame: 3 - 5 and 30 Day ]
• Number of major adverse cardiovascular and cerebral vascular events as assessed by Clinical Events Committee [ Time Frame: 30 Day ]
  All cause mortality cardiovascular mortality reinfarction, stroke/TIA, vascular complication, worsening heart failure or hemodynamic compromise requiring inotropic or hemodynamic support, repeat revascularization, aortic valve injury or dysfunction, renal failure, hemolysis, hematoma, bleeding, thromboycytopenia
• Efficacy: Infarct Size as a % of Area (Myocardium) at risk [ Time Frame: 3 - 5 and 30 Day ]
• Efficacy:Left ventricular end systolic volume index (LVESVi) [ Time Frame: 3 - 5 and 30 Day ]
• Efficacy: Left ventricular end diastolic volume index (LVEDVi) [ Time Frame: 3 - 5 and 30 Day ]
• Efficacy: Ejection Fraction (EF) [ Time Frame: 3 - 5 and 30 Day ]
• Efficacy: Percent microvascular obstruction (%MVO) [ Time Frame: 3 - 5 and 30 Day ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study
• Official Title: Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study
• Brief Summary: 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

Detailed Description

A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential role of unloading with the Impella CP prior to revascularization in reducing infarct size. The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate Arm: initiation of Impella CP unloading followed immediately by PPCI.

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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: STEMI

Intervention

Device: Impella unloading prior to PPCI

Impella unloading prior to PPCI

Study Arms

• Active Comparator: Prolonged unloading prior to PPCI
  Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention
  Intervention: Device: Impella unloading prior to PPCI
• Active Comparator: Immediate unloading prior to PPCI
  Activation of Impella CP immediately prior to primary percutaneous coronary intervention
  Intervention: Device: Impella unloading prior to PPCI

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 21, 2016): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 16, 2018
• Actual Primary Completion Date: June 19, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Main Inclusion Criteria:

• Age 21-80 years
• 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

Main Exclusion Criteria:

• Cardiogenic shock defined as: systemic hypotension (systolic BP less than 90 mmHg or the need for inotropes/pressors to maintain a systolic BP Greater than 90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the cath lab, clinical evidence of end organ hypoperfusion, lactate level greater than 2.5mmol/L
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03000270
• Other Study ID Numbers: DTU - Safety and Feasibility
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Abiomed Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Abiomed Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Abiomed Inc.
• Verification Date: November 2018