IMPACT EU Post-Market Clinical Follow-Up Study

NCT05756751 | Active Not Recruiting FDA Device

• 1 other identifier: ABMD-CIP-22-03
• Study Type: interventional
• Target: 123
• Locations: 2 countries
• Sites: 13

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.

Conditions

Left Ventricular Dysfunction

Outcome Measures

Primary Outcomes (3)

• the rate of post-cardiotomy cardiac failure

  Through Hospital Discharge, on average 1 week

• All-cause mortality

  90 Days after procedure

• Stroke (as defined by STS)

  Postoperative stroke (cerebrovascular accident) consisting of any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain that did not resolve within 24 hours.

  90 Days after procedure

Secondary Outcomes (11)

• New requirement for renal replacement therapy (RRT)

  through study completion, an average of 1 year

• Number of attempts to wean from CPB

  Until CPB was removed, on average 72 hours

• Duration of mechanical ventilation

  Through ICU Discharge, on average 3 days

• Acute Kidney Injury (a modified KDIGO stages 2-3)

  Within 7 days or at ICU discharge whichever comes first

• Adequate hemodynamic support

  Until Pulmonary Artery Catheter was removed, on average 3 days

Other Outcomes (6)

• Technical Success

  Time of CPB removed, on average at 72 hours

• Length of ICU stay in days

  Through ICU discharge, on average 3 days

• Length of hospital stay in days

  Through Hospital Discharge, on average 1 week

Study Arms (1)

Treatment with Impella 5.5 System

OTHER

Device: Device: Impella 5.5 with SmartAssist

Interventions

Device: Impella 5.5 with SmartAssist 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.

Treatment with Impella 5.5 System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)
• Age 18 years or older
• Subject has signed informed consent form and is willing and able to attend all follow-up visits and to perform all tests.
• Patient is eligible to receive the Impella 5.5 as per the current IFU.

You may not qualify if:

• 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 mechanical MCS device (such as IABP, ECMO, Impella®, CentriMag™ or TandemHeart®) in place prior to informed consent
• RV dysfunction requiring mechanical or inotropic support preoperatively and/or likely to be needed postoperatively
• 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
• Ventricular septal defect (VSD)
• Stroke within 30 days of the index cardiac surgical procedure
• Prior mantle field chest irradiation
• Prior solid organ or hematologic transplantation (heart, kidney, liver, lung, pancreas, bone marrow) or durable LVAD
• History of chronic dialysis
• Pre-existing liver dysfunction defined as Child-Pugh Class B or C
• Pre-existing pulmonary disease requiring home oxygen, or "severe pulmonary disease" determined by enrolling investigator
• Systemic active infection or evidence of systemic bacterial, fungal or viral infection within 72 hours before surgery (blood culture positive with leukocytosis)

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (13)

IKEM Prague

Prague, 14021, Czechia

Location

Universitätsklinikum Heidelberg - Klinik für Herzchirurgie

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

RWTH Uniklinik Aachen - Klinik für Herzchirurgie

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Universitätsklinikum Düsseldorf, Klinik für Herzchirurgie

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

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

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitätsmedizin Mainz, Klinik und Poliklinik für Herz- und Gefäßchirurgie

Mainz, RLP, 55131, Germany

Location

Universitätsmedizin Halle/Saale - Klinik für Herzchirurgie

Halle, SA, 06120, Germany

Location

UKSH Campus Kiel - Klinik für Herz- und Gefäßchirurgie

Kiel, Schleswig-Holstein, 24105, Germany

Location

Deutsches Herzzentrum der Charité

Berlin, 13353, Germany

Location

Universitätsklinikum Giessen

Giessen, 35392, Germany

Location

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

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier

Trier, 54292, Germany

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Hermann Reichenspurner, Prof. Dr. Dr.

  UKE Hamburg

  PRINCIPAL INVESTIGATOR

• Payam Akhyari, Prof. Dr.

  Westdeutsches Herz- und Gefäßzentrum Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Impella 5.5® with SmartAssist® (Impella 5.5®)

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: March 6, 2023
• Study Start: April 27, 2023
• Primary Completion (Estimated): August 8, 2026
• Study Completion (Estimated): August 8, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

CZ (1); DE (12)