Impella Reverse Remodeling in End-Stage Heart Failure

NCT06800716 | Recruiting DMC

• 1 other identifier: AAAV1201
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Cardiomyopathy

Keywords

cardiogenic shock and transplant; impella; LVAD

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and approximately Day 40

• 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.

  Baseline and approximately Day 40

• 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).

  Baseline and approximately Day 40

• 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).

  Baseline and approximately Day 40

Secondary Outcomes (30)

• Transplant Waitlist Outcome

  14 months

• Number of Participants Escalated

  14 months

• Waitlist time on Impella Support

  14 months

• Change in aminoterminal pro B-type natriuretic peptide (NT-proBNP)

  Baseline and approximately Day 40

• Change in Blood Urea Nitrogen (BUN)

  Baseline and approximately Day 40

Study Arms (1)

Decompensated patients on the waitlist for heart transplantation

Study participants will receive Impella 5.5 LVAD for treatment of cardiogenic shock and transplant listing as standard of care. Clinical data and serum laboratory including blood counts, end-organ function, nutritional parameters will be collected prospectively from medical records. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Evidence of acute myocarditis by endomyocardial biopsy
• Prior heart transplantation
• Mechanical aortic / mitral valve
• Patient with known aortic diseases such as Marfan-Syndrome, Morbus Erdheim-Gsell or others
• Left Ventricular thrombus
• Left Ventricular rupture
• Cardiac tamponade
• Presence of an Atrial or Ventricular Septal Defect
• Severe right ventricular (RV) Failure requiring mechanical RV support
• Severe peripheral vascular disease precluding placement of the Impella System
• Recent stroke resulting in significant neurological deficit

Sponsors & Collaborators

• Columbia University: lead
• Abiomed Inc.: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cardiac myocardium samples from the explanted heart of the transplant recipient. Serum samples from the transplant recipient.

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Adil Yunis, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adil Yunis, MD

CONTACT

212-305-0211; aay2122@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 30, 2025
• Study Start: December 4, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)