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Impella Reverse Remodeling in End-Stage Heart Failure

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at heart attack recovery in adults with a weak, enlarged heart who receive an Impella 5.5 heart pump as part of their usual care. It is for people who need the pump while waiting for a heart transplant or a decision about one. Taking part lasts about 14 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have dilated cardiomyopathy, a weak, enlarged heart. The main pumping chamber measures more than 5.5 cm across and pumps out less than 25% of its blood with each beat.
  • Your doctor decides you need an Impella 5.5 heart pump while waiting for a heart transplant or a decision about one.

Who can't join

  • You used an aortic balloon pump for more than 7 days when the Impella is placed, or had certain other heart-support devices or ECMO, a heart-lung support machine, before placement.
  • You were born with heart disease; have a stiff or thickened heart muscle, amyloidosis, or sarcoidosis; or a heart tissue test shows sudden heart muscle inflammation.
  • You have had a heart transplant, have an artificial mechanical aortic or mitral valve, or have a known disease of the aorta, the body's main artery.
  • You have a blood clot or tear in the heart's main pumping chamber, fluid pressing on the heart, or a hole in the wall between heart chambers.
  • Your heart's right side needs a support device, or severe blood vessel disease prevents placement of the Impella.
  • You recently had a stroke that caused major problems with brain or nerve function.
  • You have a clotting disorder that prevents device placement, fewer than 50,000 platelets (blood cells that help stop bleeding), or cannot take blood thinners.
  • You are pregnant, may be pregnant, or are breastfeeding, or you belong to a group considered vulnerable under the study's rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NY