Follow-up on the use of Impella 5.5 in high-risk heart surgery patients

IMpella®-Protected cArdiaC Surgery Trial in Europe: A European, Prospective, Multicenter, Post-Market Clinical Follow-Up Trial

This study is testing how safe and effective the Impella 5.5 device is for people with serious heart problems who are having high-risk heart surgeries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 123 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abiomed Inc. (Industry-sponsored)
• Locations: 13 sites (Prague and 12 other locations)
• Trial ID: NCT05756751 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to gather additional data on the safety and effectiveness of the Impella 5.5 device in patients undergoing high-risk cardiac surgeries. It is a European, prospective, multicenter, post-market clinical follow-up trial that will enroll up to 123 patients. Participants will be monitored for up to one year to assess the device's impact on post-cardiotomy cardiac failure, functional status, and quality of life in patients with severe left ventricular dysfunction.

Who should consider this trial

Good fit: Ideal candidates include hemodynamically stable patients aged 18 and older with severe left ventricular dysfunction undergoing specific cardiac surgeries.

Not a fit: Patients requiring salvage operations or those who are not hemodynamically stable may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve outcomes and quality of life for patients undergoing high-risk cardiac surgeries.

How similar studies have performed: Other studies have shown promise with similar devices in cardiac surgery, indicating potential for success in this approach.

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)

Where this trial is running

Prague and 12 other locations

• IKEM Prague — Prague, Czechia (Recruiting)
• Universitätsklinikum Heidelberg - Klinik für Herzchirurgie — Heidelberg, Bw, Germany (Recruiting)
• RWTH Uniklinik Aachen - Klinik für Herzchirurgie — Aachen, Nrw, Germany (Recruiting)
• Universitätsklinikum Düsseldorf, Klinik für Herzchirurgie — Düsseldorf, Nrw, Germany (Active_not_recruiting)
• Universitätsmedizin Essen, Westdeutsches Herzzentrum, Klinik für Thorax- und Kardiovaskuläre Medizin — Essen, Nrw, Germany (Recruiting)
• Universitätsmedizin Mainz, Klinik und Poliklinik für Herz- und Gefäßchirurgie — Mainz, Rlp, Germany (Recruiting)
• Universitätsmedizin Halle/Saale - Klinik für Herzchirurgie — Halle/Saale, Sa, Germany (Recruiting)
• UKSH Campus Kiel - Klinik für Herz- und Gefäßchirurgie — Kiel, Sh, Germany (Recruiting)
• Deutsches Herzzentrum der Charité — Berlin, Germany (Recruiting)
• Universitätsklinikum Giessen — Giessen, Germany (Recruiting)
• Universitäres Herz- und Gefäßzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie — Hamburg, Germany (Recruiting)
• Medizinische Hochschule Hannover — Hannover, Germany (Recruiting)
• Krankenhaus der Barmherzigen Brüder Trier — Trier, Germany (Recruiting)

Study contacts

• Principal investigator: Hermann Reichenspurner, Prof. Dr. Dr. — UKE Hamburg
• Study coordinator: Mohammed Naja, MD

Conditions Left Ventricular Dysfunction