IMpella-Protected cArdiaC Surgery Trial (IMPACT)

Left Ventricular Dysfunction Clinical Trial

— IMPACT  

Official title:

IMpella-Protected cArdiaC Surgery Trial (IMPACT)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05529654
• Other study ID #: VV-TMF-20447
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2024
• Source: Abiomed Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 the safety and effectiveness of using Impella 5.5 preemptively in high-risk cardiac surgery patients with severe LV dysfunction. This Trial will determine whether using the Impella 5.5 in this setting will result in an acceptable device-related safety profile.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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 replacement (MVR)

• Isolated aortic valve repair or biological replacement (AVR)

• At least two of the following: CABG, MVR, AVR, or tricuspid valve repair or replacement (TVR)

• Additional concomitant procedures permitted:

1. Atrial septal defect (ASD) or patent foramen ovale (PFO) repair or closure

2. Closure or excision of left atrial appendage (LAA)

3. Atrial fibrillation ablation procedures

4. Coronary endarterectomy

2. LVEF within 30 days before surgery of either:

• =25% measured by echocardiogram or

• LVEF =35% as above for patients with significant mitral regurgitation (MR 3+ or 4+) and planned corrective mitral valve surgery (including MV replacement or repair)

• Any subject with EF <20% must have viability assessment performed to assess CABG candidacy (MRI preferred)

3. Age 18 years or older

4. Subject (or subject's LAR, if allowed by IRB) has signed Informed Consent Form

Exclusion Criteria:

1. Salvage operation (cardiac arrest within 24 hours prior to index surgery)

2. Unresponsive state within 24 hours of the time of surgery

3. Any inotrope within 72 hours of surgery

4. Any MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place prior to informed consent

5. RV dysfunction requiring mechanical or inotropic support pre-operatively and/or likely to be needed post-operatively

6. 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

7. Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade or other conditions in which cardiac output is dependent on venous return

8. Ventricular septal defect (VSD)

9. Stroke within 30 days of the index cardiac surgical procedure

10. Prior mantle field chest irradiation

11. Prior solid organ or hematologic transplantation (heart, kidney, liver, lung, pancreas, bone marrow) or durable LVAD

12. History of chronic dialysis

13. Pre-existing liver dysfunction defined as: Child-Pugh Class B or C

14. Pre-existing pulmonary disease requiring home oxygen or "severe pulmonary disease" determined by enrolling Investigator

15. Systemic active infection or evidence of systemic bacterial, fungal or viral infection within 72 hours before surgery (blood culture positive with leukocytosis)

16. Confirmed COVID-19 infection within two weeks prior to operation

17. Suspected or known pregnancy

18. Participation in the active treatment or follow-up phase of another interventional clinical trial of an investigational drug or device which has not reached its primary endpoint

19. Known contraindication to heparin; History of bleeding diathesis or known coagulopathy or will refuse blood transfusions

20. Inability to perform aortic cross-clamp, such as due to porcelain aorta

21. Any contraindication or inability to place Impella 5.5 (per the IFU), including LV thrombus and/or presence of a mechanical aortic valve

22. Any organ condition, concomitant disease (e.g., psychiatric illness, current severe alcoholism or current drug abuse, cancer, hepatic or kidney disease), with life expectancy of =2 years or other abnormality that itself or the treatment of which, could interfere with the conduct of the Trial or that, in the opinion of the Investigator and/or Sponsor's Medical Monitor, would pose an unacceptable risk to the subject in the Trial.

23. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with trial procedures

24. Subject belongs to a vulnerable population [Vulnerable Patient Populations are defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention]

Related Conditions & MeSH terms

• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• Impella 5.5 with SmartAssist
For subjects enrolled in the Trial, the Impella 5.5 will be placed intra-operatively during the index cardiac surgical procedure

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Brigham & Women's	Boston	Massachusetts
United States	Mass General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Keck School of Medicine	Los Angeles	California
United States	Centennial Heart Cardiovascular	Nashville	Tennessee
United States	New York- Presbyterian Hospital/ Columbia University Medical Center	New York	New York
United States	NYU Langone Health	New York	New York
United States	Hospital of The University of Pennsylvania	Philadelphia	Pennsylvania
United States	Baylor Scott and White - Plano	Plano	Texas
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of All-Cause Mortality		90 days
Primary	Stroke (as defined by STS)		90 days
Primary	New requirement for Renal Replacement Therapy (RRT)		90 days
Secondary	Number of attempts to wean from CPB		Intra-op, usually within 1 day
Secondary	Duration of mechanical ventilation		ICU discharge, usually within 30 days
Secondary	Duration of mechanical support (hours)		ICU Discharge, usually within 30 days
Secondary	Acute Kidney Injury	a modified KDIGO Stages 2-3	within 7 days or at ICU Discharge
Secondary	Dosages for inotropic/vasopressor (Hours)	measured in number of hours of dosage	ICU Discharge, usually within 30 days
Secondary	Cardiovascular mortality		Hospital discharge, usually within 30 days
Secondary	Major Hemolysis	defined by MCS-ARC	Hospital Discharge, usually within 30 days
Secondary	Major Vascular Complications	defined by MCS-ARC	Hospital Discharge, usually within 30 days
Secondary	Major Bleeding	defined by STS	Hospital Discharge, usually within 30 days
Secondary	Length of ICU Stay		ICU Discharge, usually within 30 days
Secondary	Length of Hospital Stay		Hospital Discharge, usually within 30 days
Secondary	Quality of Life (QoL) assessed by KCCQ		90 Days Post-Op
Secondary	Physical Activity	Measured by (Katz Activities of Daily Living (ADL) and Lawton Instrumental ADL (IADL)	90 Days Post-Op
Secondary	Technical Success	The successful use of the Impella 5.5 device will be assessed by the proportion of patients who undergo successful Impella implant, as well as the proportion of patients demonstrating successful wean off CPB.	Intra-op, usually within 1 day