N/A
N=211
Identifying and Facilitating Ventricular Recovery on Mechanical Support
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00687856 ↗Enrolled (actual)
211
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Number of Subjects With Left Ventricular Recovery and LVAD Explant — 8 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Echocardiogram (echo) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Left Ventricular Recovery and LVAD Explant |
8 | — |
| SECONDARY Refine and Test Feedback Control Algorithm That Allows Precise Prescription of Cardiac Loading Through Synchronized and Asynchronized LVAD Operation With Native Left Ventricular Contraction |
— | — |
Summary
Heart failure is a progressive disorder in which the weakened heart is not able to efficiently pump blood throughout the body. When the body's cells do not receive enough blood, this can result in fatigue, shortness of breath, and difficulty carrying out daily activities. The left ventricular assist device (LVAD) is a device that is used to provide mechanical circulatory support to patients with end-stage heart failure who are awaiting heart transplants. Although LVAD support helps maintain the pumping ability of the heart and dramatically improves heart failure symptoms, the quality of life with LVAD support is far from ideal. It has been shown that LVAD support in selected patients may restore the failing heart enough to eliminate the need for heart transplant, but more information is needed to assess heart recovery and to guide weaning of LVAD support. Using data collected from patients who have undergone LVAD implantation, this study will attempt to better assess heart recovery and to generate criteria for identifying patients eligible for the removal of LVAD support.
Eligibility Criteria
Inclusion Criteria
- Eligible to receive an LVAD or biventricular assist device (BIVAD) for clinical indications.
Exclusion Criteria
- Refuses LVAD support
- Requires right ventricular assist device (RVAD) placement alone
- In atrial fibrillation with a ventricular response of greater than 120 beats per minute
Data sourced from ClinicalTrials.gov (NCT00687856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.