Impella Reverse Remodeling in End-Stage Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorColumbia University
About this trial
This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care. There are three stages in this study: screening, treatment and post treatment. There will be two phases of enrollment: First phase will enroll 10 patients; second phase will enroll an additional 40 patients. Approximately 50 participants will take part in the study at Columbia University Irving Medical Center.
Participation in this research is expected to last approximately 14 months. This time estimate includes a screening period for about 1- 3 days, treatment period of 40 days and post treatment follow-up period for 1 year. Data will be collected through 1- year after heart transplant. Clinical data (medical history, vital signs, laboratory assessments) from medical records, to perform functional testing, and to obtain blood and discarded heart tissue fromfor the purpose of this research study.
Participants will be asked to share their records for echocardiography, right heart catheterization, laboratory data and clinical information. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or older
Dilated cardiomyopathy (LVEDD > 5.5 cm and LVEF <25%)
Indication for temporary mechanical circulatory support therapy with Impella 5.5 LVAD as a bridge to transplant or bridge to transplant decision based on treating physician's discretion
Disqualifiers
Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation
Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation
Congenital heart disease
Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis
Trial population
Inpatients at Columbia University Irving Medical Center, who are waitlisted for heart transplant with a clinical indication for Impella 5.5 left ventricular assist device (LVAD) placement.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Decompensated patients on the waitlist for heart transplantation
Trial outcomes
Primary outcomes
1
Change in Left Ventricular Ejection Fraction (LVEF)
A change in echocardiographic index will be evaluated by measuring a change in LVEF before and after Impella support at minimal pump setting.
Time frame
Baseline and approximately Day 402
Change in Left Ventricular End-Diastolic Diameter (LVEDD)
A change in echocardiographic index will be evaluated by measuring a change in LVEDD before and after Impella support at minimal pump setting.
Time frame
Baseline and approximately Day 403
Change in Cardiac Index
A change in hemodynamics will be evaluated by measuring a change in cardiac index before and after Impella support at minimal pump speed setting (P2).
Time frame
Baseline and approximately Day 404
Change in Pulmonary Capillary Wedge Pressure
A change in hemodynamics will be evaluated by measuring a change in Pulmonary Capillary Wedge Pressure before and after Impella support at minimal pump speed setting (P2).
Time frame
Baseline and approximately Day 40Secondary outcomes
1
Transplant Waitlist Outcome
The transplant waitlist outcome will be evaluated and the number of participants who die, are delisted due to worsening clinical condition, are transplanted, or are delisted for recovery will be reported.
Time frame
14 months2
Number of Participants Escalated
Number of participants escalated to extracorporeal membrane oxygenation (ECMO) or other temporary/durable mechanical circulatory support (MCS).
Time frame
14 months3
Waitlist time on Impella Support
Waitlist time on Impella support measured in days from the date of Impella insertion to heart transplantation or other waitlist end-point.
Time frame
14 months4
Change in aminoterminal pro B-type natriuretic peptide (NT-proBNP)
Change in NT-proBNP levels collected from blood samples and measured in pg/mL.
Time frame
Baseline and approximately Day 40Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Abiomed Inc.
Collaborator
Source ClinicalTrials.gov