IMpella-Protected cArdiaC Surgery Trial (IMPACT)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Left Ventricular Dysfunction
- Sponsor
- Abiomed Inc.
- Enrollment
- 100
- Locations
- 20
- Primary Endpoint
- Composite of All-Cause Mortality
- Status
- Active, Not Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5) peri-operatively improves early hemodynamics, end-organ function and clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.
Detailed Description
This is a prospective single-armed Trial to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients. A concurrent Registry will also be performed to collect information on patients meeting Exclusion Criteria and those not approached for enrollment. The overall aim is to evaluate if using Impella 5.5 peri-operatively improves early hemodynamics, end-organ function and subsequent clinical outcomes in patients with severely reduced LV function undergoing cardiac surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Hemodynamically stable patients undergoing one of the following cardiac surgery procedures on CPB including aortic cross-clamping and cardioplegic arrest:
- •Isolated CABG
- •Isolated mitral valve repair or mitral valve replacement (MVR)
- •Isolated biological aortic valve replacement (AVR)
- •At least two of the following: CABG, MVR, AVR, or tricuspid valve repair or replacement (TVR)
- •Additional concomitant procedures permitted:
- •Atrial septal defect (ASD) or patent foramen ovale (PFO) repair or closure
- •Atrial fibrillation ablation procedures
- •Left atrial ablation (all forms including complete left/right side Cox Maze)
- •Coronary endarterectomy
Exclusion Criteria
- •Salvage operation (cardiac arrest within 24 hours prior to index surgery)
- •Unresponsive state within 24 hours of the time of surgery
- •Any inotrope within 72 hours of surgery
- •Any MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place at time of informed consent and less than 24 hours prior to index study procedure
- •RV dysfunction requiring mechanical or inotropic support pre-operatively and/or likely to be needed post-operatively
- •Index procedures requiring total circulatory arrest (TCA), such as aortic arch replacement, planned durable LVAD, durable RVAD, planned right-sided temporary mechanical support of any kind, total artificial heart (TAH), cardiac transplantation, pericardiectomy, pulmonary thromboendarterectomy and septal myectomy
- •Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade or other conditions in which cardiac output is dependent on venous return
- •Ventricular septal defect (VSD)
- •Stroke within 30 days of the index cardiac surgical procedure
- •Prior mantle field chest irradiation
Outcomes
Primary Outcomes
Composite of All-Cause Mortality
Time Frame: 90 days
Stroke (as defined by STS)
Time Frame: 90 days
New requirement for Renal Replacement Therapy (RRT)
Time Frame: 90 days
Rate of Post-Cardiotomy Cardiac Failure
Time Frame: Hospital discharge, usually within 30 days
The rate of post-cardiotomy cardiac failure evaluated at hospital discharge.
Secondary Outcomes
- Number of attempts to wean from CPB(Intra-op, usually within 1 day)
- Duration of mechanical ventilation(ICU discharge, usually within 30 days)
- Duration and dosages of inotropes and vasopressors. Duration of mechanical circulatory support (Hours)(ICU Discharge, usually within 30 days)
- Acute Kidney Injury(within 7 days or at ICU Discharge (usually within 30 days))
- Vasoactive-inotropic score (VIS)(ICU Discharge, usually within 30 days)
- Cardiovascular mortality(Hospital discharge, usually within 30 days)
- Major Hemolysis(Hospital Discharge, usually within 30 days)
- Major Vascular Complications(Hospital Discharge, usually within 30 days)
- Major Bleeding(Hospital Discharge, usually within 30 days)
- Length of ICU Stay(ICU Discharge, usually within 30 days)
- Length of Hospital Stay(Hospital Discharge, usually within 30 days)
- Quality of Life (QoL) assessed by KCCQ(90 Days Post-Op)
- Physical Activity(90 Days Post-Op)
- Technical Success(Intra-op, usually within 1 day)