Clinical trial NCT05756751: IMPACT EU Post-Market Clinical Follow-Up Study
Official title: IMpella®-Protected cArdiaC Surgery Trial in Europe: A European, Prospective, Multicenter, Post-Market Clinical Follow-Up Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Left Ventricular Dysfunction
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Impella 5.5® with SmartAssist® (Impella 5.5®)
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to collect further data on the safety and on the effectiveness of the use of Impella 5.5® in high-risk cardiac surgery patients.

Detailed description: A European, prospective, multicenter, post-market clinical single-arm follow-up trial.

Up to 123 patients will be enrolled in the study.

Patients will be followed for up to 1-year.

The objectives of the study are to collect data on the safety and on the effectiveness of the Impella 5.5 System in mitigating post-cardiotomy cardiac failure, as well as improving functional status and quality of life (QoL) in high-risk cardiac surgery patients with severe LV dysfunction in a post-market setting.

Eligibility criteria: Inclusion Criteria:

1. Hemodynamically stable patients undergoing one (1) 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 replacement (AVR)
   * At lest two of the following: CABG, MVR, AVR, or tricuspid valve repair or replacement (TVR)
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+; see definition) and planned corrective mitral valve surgery (including MV replacement or repair)
3. Age 18 years or older
4. Subject has signed informed consent form and is willing and able to attend all follow-up visits and to perform all tests.
5. Patient is eligible to receive the Impella 5.5 as per the current IFU.

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 mechanical MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place prior to informed consent
5. RV dysfunction requiring mechanical or inotropic support preoperatively and/or likely to be needed postoperatively
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 (2) weeks prior to operation
17. Pregnant or planning pregnancy within next 12 months. NOTE: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention.
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 condition that would prevent the ability to place Impella 5.5® (per current 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 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, including patients under guardianship
24. Any subject considered to be part of a vulnerable population (as per ISO 14155)

Primary outcomes:
measure: the rate of post-cardiotomy cardiac failure
timeFrame: Through Hospital Discharge, on average 1 week
measure: All-cause mortality
timeFrame: 90 Days after procedure
measure: Stroke (as defined by STS)
timeFrame: 90 Days after procedure
Secondary outcomes:
measure: New requirement for renal replacement therapy (RRT)
timeFrame: through study completion, an average of 1 year
measure: Number of attempts to wean from CPB
timeFrame: Until CPB was removed, on average 72 hours
measure: Duration of mechanical ventilation
timeFrame: Through ICU Discharge, on average 3 days
measure: Acute Kidney Injury (a modified KDIGO stages 2-3)
timeFrame: Within 7 days or at ICU discharge whichever comes first
measure: Adequate hemodynamic support
timeFrame: Until Pulmonary Artery Catheter was removed, on average 3 days
measure: Vasoactive-inotropic score (VIS)
timeFrame: Through ICU Discharge, on average 3 days
measure: Cardiovascular mortality
timeFrame: Through Hospital Discharge, on average 1 week
measure: Major Hemolysis (defined by MCS-ARC)
timeFrame: Through Hospital Discharge, on average 1 week
measure: Major Vascular Complications (defined by MCS-ARC)
timeFrame: Through Hospital Discharge, on average 1 week
measure: Major Bleeding defined by STS
timeFrame: Through Hospital Discharge, on average 1 week
measure: All-cause Mortality
timeFrame: Up to 1-year post-op
Other outcomes:
measure: Technical Success
timeFrame: Time of CPB removed, on average at 72 hours
measure: Length of ICU stay in days
timeFrame: Through ICU discharge, on average 3 days
measure: Length of hospital stay in days
timeFrame: Through Hospital Discharge, on average 1 week
measure: Quality of Life Assessment by Kansas City Cardiomyopathy Questionnaire KCCQ)
timeFrame: 90 days and 1-year post-op
measure: Quality of Life by Assessment of physical activity
timeFrame: 90 days and 1-year post-op
measure: Quality of Life (QoL) by assessing the ability to perform tasks necessary to live independently
timeFrame: 90 days and 1-year post-op
Locations:
city: Prague
country: Czechia
facility: IKEM Prague
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg - Klinik für Herzchirurgie
state: BW
city: Aachen
country: Germany
facility: RWTH Uniklinik Aachen - Klinik für Herzchirurgie
state: NRW
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf, Klinik für Herzchirurgie
state: NRW
city: Essen
country: Germany
facility: Universitätsmedizin Essen, Westdeutsches Herzzentrum, Klinik für Thorax- und Kardiovaskuläre Medizin
state: NRW
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, Klinik und Poliklinik für Herz- und Gefäßchirurgie
state: RLP
city: Halle/Saale
country: Germany
facility: Universitätsmedizin Halle/Saale - Klinik für Herzchirurgie
state: SA
city: Kiel
country: Germany
facility: UKSH Campus Kiel - Klinik für Herz- und Gefäßchirurgie
state: SH
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
Study officials:
affiliation: UKE Hamburg
name: Hermann Reichenspurner, Prof. Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Westdeutsches Herz- und Gefäßzentrum Essen
name: Payam Akhyari, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: