The Use of Impella RP Support System in Patients With Right Heart Failure
Primary Purpose
Right Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IMPELLA® RP
Sponsored by
About this trial
This is an interventional treatment trial for Right Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients that have developed signs of right ventricular failure either: A) within 48 hours post-implantation of an FDA approved implantable surgical LVAD (left ventricular assist device )(Cohort A) or B) subsequent to postcardiotomy shock within 48 hours post surgery or post myocardial infarction (Cohort B).
- Age ≥18 years old
- Signed Informed consent
Exclusion Criteria
- INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
- Evidence of acute neurologic injury
- RA(right atrium),RV (right Ventricle) and/or PA (pulmonary artery) thrombus
- Intolerance to anticoagulant or antiplatelet therapies
- Existing congenital heart disease that would preclude the insertion of the device.
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome
- Acute Myocardial Infarction (AMI) with mechanical complications ( ventricular septal defect, myocardial rupture, papillary muscle rupture)
Sites / Locations
- Henry Ford HospitalRecruiting
- Albert Einstein Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Outcomes
Primary Outcome Measures
Primary Benefit Endpoint
Survival at 30 days or hospital discharge whichever is longer post device explant or to the next therapy, including transplant, bridge to transplant or destination therapy with FDA approved surgical VAD (Ventricular Assit Device).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01777607
Brief Title
The Use of Impella RP Support System in Patients With Right Heart Failure
Official Title
The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abiomed Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
IMPELLA® RP
Primary Outcome Measure Information:
Title
Primary Benefit Endpoint
Description
Survival at 30 days or hospital discharge whichever is longer post device explant or to the next therapy, including transplant, bridge to transplant or destination therapy with FDA approved surgical VAD (Ventricular Assit Device).
Time Frame
30 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients that have developed signs of right ventricular failure either: A) within 48 hours post-implantation of an FDA approved implantable surgical LVAD (left ventricular assist device )(Cohort A) or B) subsequent to postcardiotomy shock within 48 hours post surgery or post myocardial infarction (Cohort B).
Age ≥18 years old
Signed Informed consent
Exclusion Criteria
INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
Evidence of acute neurologic injury
RA(right atrium),RV (right Ventricle) and/or PA (pulmonary artery) thrombus
Intolerance to anticoagulant or antiplatelet therapies
Existing congenital heart disease that would preclude the insertion of the device.
Participation in any other clinical investigation that is likely to confound study results or affect study outcome
Acute Myocardial Infarction (AMI) with mechanical complications ( ventricular septal defect, myocardial rupture, papillary muscle rupture)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William O.Neill, MD
Organizational Affiliation
Henry Ford Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Anderson, MD
Organizational Affiliation
Albert Einstein Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Fox, RN
Phone
313-916-1879
Email
mfox2@hfhs.org
First Name & Middle Initial & Last Name & Degree
William O'Neill, MD
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggie Flynn
Phone
267-421-7439
Email
FlynnMag@einstein.edu
First Name & Middle Initial & Last Name & Degree
Mark Anderson, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
26681124
Citation
Anderson MB, Goldstein J, Milano C, Morris LD, Kormos RL, Bhama J, Kapur NK, Bansal A, Garcia J, Baker JN, Silvestry S, Holman WL, Douglas PS, O'Neill W. Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant. 2015 Dec;34(12):1549-60. doi: 10.1016/j.healun.2015.08.018. Epub 2015 Sep 8.
Results Reference
derived
Learn more about this trial
The Use of Impella RP Support System in Patients With Right Heart Failure
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