Impella Reverse Remodeling in End-Stage Heart Failure

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06800716
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Dec 4, 2024
Status verified
Jul 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Baseline and approximately Day 40 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia UniversityNew YorkNew York10032
Kate Dalton, MS
[email protected]
347-514-3366
Adil Yunis, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Columbia University· New York, NY

Related Studies