IMpella-Protected cArdiaC Surgery Trial (IMPACT) (NCT05529654) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
IMpella-Protected cArdiaC Surgery Trial (IMPACT)
United States100 participantsStarted 2023-09-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Hemodynamically stable patients undergoing one of the following cardiac surgery procedures on CPB including aortic cross-clamping and cardioplegic arrest:
. 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
. LVEF within 30 days before surgery of either:
. Age 18 years or older
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of All-Cause Mortality
Timeframe: 90 days
2
Stroke (as defined by STS)
Timeframe: 90 days
3
New requirement for Renal Replacement Therapy (RRT)
Timeframe: 90 days
4
Rate of Post-Cardiotomy Cardiac Failure
Timeframe: Hospital discharge, usually within 30 days
. Subject (or subject's LAR, if allowed by IRB) has signed Informed Consent Form
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