RECRUITING

Impella Reverse Remodeling in End-Stage Heart Failure

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Conditions

Heart FailureCardiomyopathycardiogenic shock and transplantimpellaLVAD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective Study of Recovery Mechanisms in Heart Transplant Eligible Patients With Cardiogenic Shock on Impella 5.5 Support

Quick Facts

Study Start:2024-12-04
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06800716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Dilated cardiomyopathy (LVEDD \> 5.5 cm and LVEF \<25%)
  3. * 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
  1. * Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation
  2. * Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation
  3. * Congenital heart disease
  4. * Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis
  5. * Evidence of acute myocarditis by endomyocardial biopsy
  6. * Prior heart transplantation
  7. * Mechanical aortic / mitral valve
  8. * Patient with known aortic diseases such as Marfan-Syndrome, Morbus Erdheim-Gsell or others
  9. * Left Ventricular thrombus
  10. * Left Ventricular rupture
  11. * Cardiac tamponade
  12. * Presence of an Atrial or Ventricular Septal Defect
  13. * Severe right ventricular (RV) Failure requiring mechanical RV support
  14. * Severe peripheral vascular disease precluding placement of the Impella System
  15. * Recent stroke resulting in significant neurological deficit
  16. * Hypercoagulable disease precluding device implantation
  17. * Severe thrombocytopenia (\<50,000)
  18. * Contraindication to anticoagulation
  19. * Suspected or known pregnancy or lactating women
  20. * Subject belongs to a vulnerable population

Contacts and Locations

Study Contact

Adil Yunis, MD
CONTACT
212-305-0211
aay2122@cumc.columbia.edu

Principal Investigator

Adil Yunis, MS
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Adil Yunis, MS, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-04
Study Completion Date2027-11

Study Record Updates

Study Start Date2024-12-04
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • cardiogenic shock and transplant
  • impella
  • LVAD

Additional Relevant MeSH Terms

  • Heart Failure
  • Cardiomyopathy