Recruiting

Impella

Sponsor:

Columbia University

Code:

NCT06800716

Conditions

Heart Failure

Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT06800716

Start date

Dec 4, 2024

Status verified date

Aug, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Hypercoagulable disease precluding device implantation
  • Severe thrombocytopenia (<50,000)
  • Contraindication to anticoagulation
  • Suspected or known pregnancy or lactating women
  • Subject belongs to a vulnerable population

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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 ]
  • Change in Left Ventricular End-Diastolic Diameter (LVEDD) [ Time Frame: Baseline and approximately Day 40 ]
  • Change in Cardiac Index [ Time Frame: Baseline and approximately Day 40 ]
  • Change in Pulmonary Capillary Wedge Pressure [ Time Frame: Baseline and approximately Day 40 ]

Central Contacts and Locations

Central contacts

Adil Yunis, MD

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

Locations

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Kate Dalton, MS

(347)514-3366keb2114@cumc.columbia.edu

Principal Investigator:

Adil Yunis, MD

More Information

Sponsor

Columbia University

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • cardiogenic shock and transplant
  • impella
  • LVAD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Columbia University on 2026-08-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.