IMPACT EU Post-Market Clinical Follow-Up Study

NCT ID: NCT05756751

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2026-08-08

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.

Conditions

Left Ventricular Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with Impella 5.5 System

Group Type: OTHER

Device: Impella 5.5 with SmartAssist

Intervention Type: DEVICE

Patients who are deemed high-risk due to low preoperative ejection fraction undergoing cardiac surgery with cardiopulmonary bypass (CPB) which will be supported by the Impella 5.5 System.

Interventions

Device: Impella 5.5 with SmartAssist

Patients who are deemed high-risk due to low preoperative ejection fraction undergoing cardiac surgery with cardiopulmonary bypass (CPB) which will be supported by the Impella 5.5 System.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hermann Reichenspurner, Prof. Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

UKE Hamburg

Payam Akhyari, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Westdeutsches Herz- und Gefäßzentrum Essen

Locations

IKEM Prague

Prague, , Czechia

Universitätsklinikum Heidelberg - Klinik für Herzchirurgie

Heidelberg, Baden-Wurttemberg, Germany

RWTH Uniklinik Aachen - Klinik für Herzchirurgie

Aachen, North Rhine-Westphalia, Germany

Universitätsklinikum Düsseldorf, Klinik für Herzchirurgie

Düsseldorf, North Rhine-Westphalia, Germany

Universitätsmedizin Essen, Westdeutsches Herzzentrum, Klinik für Thorax- und Kardiovaskuläre Medizin

Essen, North Rhine-Westphalia, Germany

Universitätsmedizin Mainz, Klinik und Poliklinik für Herz- und Gefäßchirurgie

Mainz, RLP, Germany

Universitätsmedizin Halle/Saale - Klinik für Herzchirurgie

Halle, SA, Germany

UKSH Campus Kiel - Klinik für Herz- und Gefäßchirurgie

Kiel, Schleswig-Holstein, Germany

Deutsches Herzzentrum der Charité

Berlin, , Germany

Universitätsklinikum Giessen

Giessen, , Germany

Universitäres Herz- und Gefäßzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Krankenhaus der Barmherzigen Brüder Trier

Trier, , Germany

Countries

Czechia; Germany

Other Identifiers

ABMD-CIP-22-03

Identifier Type: -

Identifier Source: org_study_id