search
Back to results

IMPACT EU Post-Market Clinical Follow-Up Study

Primary Purpose

Left Ventricular Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Device: Impella 5.5 with SmartAssist
Sponsored by
Abiomed Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Ventricular Dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Mitral and tricuspid valve repair or replacement (MVR/TVR) CABG and mitral valve repair or replacement (CABG/MVR) CABG and mitral valve repair or replacement and tricuspid valve repair or replacement (CABG/MVR/TVR) CABG and tricuspid valve repair or replacement (CABG/TVR) LVEF within 30 days before surgery of either: ≤30% 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. Exclusion Criteria: Salvage operation (cardiac arrest within 24 hours prior to index surgery) Unresponsive state within 24 hours of the time of surgery Cardiogenic shock at the time of index 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) Confirmed COVID-19 infection within two (2) weeks prior to operation 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. 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 Known contraindication to heparin; History of bleeding diathesis or known coagulopathy or will refuse blood transfusions Inability to perform aortic cross-clamp, such as due to porcelain aorta 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 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. 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 Any subject considered to be part of a vulnerable population (as per ISO 14155)

Sites / Locations

  • Universitätsklinikum Heidelberg - Klinik für Herzchirurgie
  • RWTH Uniklinik Aachen - Klinik für HerzchirurgieRecruiting
  • Universitätsmedizin Halle/Saale - Klinik für HerzchirurgieRecruiting
  • UKSH Campus Kiel - Klinik für Herz- und GefäßchirurgieRecruiting
  • Deutsches Herzzentrum der CharitéRecruiting
  • Universitäres Herz- und Gefäßzentrum Hamburg - Klinik und Poliklinik für Herz- und GefäßchirurgieRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment with Impella 5.5 System

Arm Description

Outcomes

Primary Outcome Measures

the rate of post-cardiotomy cardiac failure
All-cause mortality and Safety Endpoint: Stroke (as defined by STS)
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.

Secondary Outcome Measures

New requirement for renal replacement therapy (RRT)
Number of attempts to wean from CPB
Duration and dosages of vasopresor ssupport in hours
Duration and dosages of inotropic support in hours
Acute Kidney Injury (a modified KDIGO stages 2-3)
Adequate hemodynamic support
Major Hemolysis (defined by MCS-ARC)
Major Vascular Complications (defined by MCS-ARC)
Major Bleeding defined by STS
Bleeding requiring surgical intervention or fatal bleeding
All-cause Mortality

Full Information

First Posted
January 20, 2023
Last Updated
October 23, 2023
Sponsor
Abiomed Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05756751
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abiomed Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 with an adaptive design. The study will first include up to 123 patients, but the adaptive mechanism can allow the sample size to increase up to 535 patients. 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 improving functional status and quality of life (QoL) in high-risk cardiac surgery patients with severe LV dysfunction in a post-market setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Impella 5.5® with SmartAssist® (Impella 5.5®)
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Impella 5.5 System
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Device: Impella 5.5 with SmartAssist
Intervention Description
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.
Primary Outcome Measure Information:
Title
the rate of post-cardiotomy cardiac failure
Time Frame
Through Hospital Discharge, on average 1 week
Title
All-cause mortality and Safety Endpoint: Stroke (as defined by STS)
Time Frame
90 Days after procedure
Title
Stroke (as defined by STS)
Description
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.
Time Frame
90 Days after procedure
Secondary Outcome Measure Information:
Title
New requirement for renal replacement therapy (RRT)
Time Frame
through study completion, an average of 1 year
Title
Number of attempts to wean from CPB
Time Frame
Until CPB was removed, on average 72 hours
Title
Duration and dosages of vasopresor ssupport in hours
Time Frame
Through ICU Discharge, on average 3 days
Title
Duration and dosages of inotropic support in hours
Time Frame
Through ICU Discharge, on average 3 days
Title
Acute Kidney Injury (a modified KDIGO stages 2-3)
Time Frame
Within 7 days or at ICU discharge whichever comes first
Title
Adequate hemodynamic support
Time Frame
Through ICU Discharge, on average 3 days
Title
Major Hemolysis (defined by MCS-ARC)
Time Frame
Through Hospital Discharge, on average 1 week
Title
Major Vascular Complications (defined by MCS-ARC)
Time Frame
Through Hospital Discharge, on average 1 week
Title
Major Bleeding defined by STS
Description
Bleeding requiring surgical intervention or fatal bleeding
Time Frame
Through Hospital Discharge, on average 1 week
Title
All-cause Mortality
Time Frame
Up to 1-year post-op
Other Pre-specified Outcome Measures:
Title
Technical Success
Description
The successful use of the Impella 5.5 device will be assessed by the proportion of patients who undergo successful Impella insertion, as well as the proportion of patients demonstrating successful wean off CPB
Time Frame
Time of CPB removed, on average at 72 hours
Title
Length of ICU stay in days
Time Frame
Through ICU discharge, on average 3 days
Title
Length of hospital stay in days
Time Frame
Through Hospital Discharge, on average 1 week
Title
Quality of Life Assessment by Kansas City Cardiomyopathy Questionnaire KCCQ)
Description
KCCQ scores are scaled from 0 to 100. Lower scores representing the worse symptoms
Time Frame
90 days and 1-year post-op
Title
Quality of Life by Assessment of physical activity
Description
(Katz Activities of Daily Living (ADL). A The summary score ranges from 0 (low function, dependent) to 8 (high function, independent).
Time Frame
90 days and 1-year post-op
Title
Quality of Life (QoL) by assessing the ability to perform tasks necessary to live independently
Description
Assessed by LAWTON - BRODY instrumental activities of daily living scale (I.A.D.L.). A summary score ranges from 0 (Low, patient very dependent ) to 6 (high, patient independent)
Time Frame
90 days and 1-year post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Mitral and tricuspid valve repair or replacement (MVR/TVR) CABG and mitral valve repair or replacement (CABG/MVR) CABG and mitral valve repair or replacement and tricuspid valve repair or replacement (CABG/MVR/TVR) CABG and tricuspid valve repair or replacement (CABG/TVR) LVEF within 30 days before surgery of either: ≤30% 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. Exclusion Criteria: Salvage operation (cardiac arrest within 24 hours prior to index surgery) Unresponsive state within 24 hours of the time of surgery Cardiogenic shock at the time of index 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) Confirmed COVID-19 infection within two (2) weeks prior to operation 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. 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 Known contraindication to heparin; History of bleeding diathesis or known coagulopathy or will refuse blood transfusions Inability to perform aortic cross-clamp, such as due to porcelain aorta 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 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. 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 Any subject considered to be part of a vulnerable population (as per ISO 14155)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Goetzenich, Prof. Dr. Dr.
Phone
+49 241 8860
Ext
0
Email
agoetzenich@abiomed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kirstin Starke
Phone
+49 241 8860
Ext
0
Email
kstarke@abiomed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hermann Reichenspurner, Prof. Dr. Dr.
Organizational Affiliation
UKE Hamburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Payam Akhyari, Prof. Dr.
Organizational Affiliation
Uniklinik RWTH Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Heidelberg - Klinik für Herzchirurgie
City
Heidelberg
State/Province
BW
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
RWTH Uniklinik Aachen - Klinik für Herzchirurgie
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Payam Akhyari, MD
Email
herzchirurgie@ukaachen.de
Email
herzchirurgie@ukaachen.de
First Name & Middle Initial & Last Name & Degree
Payam Akhyari, MD
Facility Name
Universitätsmedizin Halle/Saale - Klinik für Herzchirurgie
City
Halle/Saale
State/Province
SA
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gábor Veres
First Name & Middle Initial & Last Name & Degree
Gábor Veres, MD
Facility Name
UKSH Campus Kiel - Klinik für Herz- und Gefäßchirurgie
City
Kiel
State/Province
SH
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernd Panholzer
First Name & Middle Initial & Last Name & Degree
Bernd Panholzer, MD
Facility Name
Deutsches Herzzentrum der Charité
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgenij Potapov, MD
First Name & Middle Initial & Last Name & Degree
Evgenij Potapov, MD
Facility Name
Universitäres Herz- und Gefäßzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Bernhardt, MD
First Name & Middle Initial & Last Name & Degree
Alexander Bernhardt

12. IPD Sharing Statement

Learn more about this trial

IMPACT EU Post-Market Clinical Follow-Up Study

We'll reach out to this number within 24 hrs