Interagency Registry of Mechanically Assisted Circulatory Support

Study ID
STU 082010-019

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul

Contact
Sangita Sethuram
214-645-7728
sangita.sethuram@utsouthwestern.edu

Principal Investigator
Dan Meyer

Summary

Protocol 3.0:

This is an observational registry of clinical events. Patients will be asked to sign an informed consent document that includes permission to:
- Collect clinical data from their medical chart.
- administer a short quality of life questionnaire.
- administer the trail neurocognitive test.
- Complete a functional capacity test (6-minute walk and 15 foot walk)

Protocol 4.0:

each patient who receives an MCSD at an institution will be screened according to the eligibility criteria listed below. For patients who do not meet the inclusion criteria, the following information will be recorded on the screening log: gender, race, age decade, brand of the implanted device (left or right side of the heart), date of implant, patient in an MCSD clinical trial, and death should it occur within 2 days of implant. This basic information is necessary to assess completeness of patient capture and possible bias in the registry. no further information will be collected on patients who do not meet the inclusion criteria. inTeRMaCS[RegisteredTM] collects information pertaining to patients, care providers, hospitals, and devices. Most of these data are collected through chart review by nurse coordinators and physicians at the clinical sites. Standard of care Quality of life (QoL) and functional capacity data are collected for adults and pediatric patients through administration of instruments and tests. additionally, standard of care neurocognitive data are collected for adults. While inTeRMaCS[RegisteredTM] was intended to be primarily a prospective registry when it was first established, in actuality the data are collected retrospectively from existing medical records or concurrently in the normal course of treatment on patients who meet the eligibility criteria. additional standard of care evaluations and contact with the patient outside of the index hospitalization are required for this registry. Specifically, post implant follow up data are collected at 1 week, 1 month, 3 months, 6 months and every 6 months after that for up to 1 year after the device is explanted. Physical examination and functional capacity testing is a routine portion of the care for these patients; the interview consists of survey questions from the euroQoL (eQ-5D-3L), Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Trail Making neurocognitive Test, Part B assessment.


*

Participant Eligibility

Protocol 3.0: Study participation is limited to patients receiving or have received a ventricular assist device at this facility.

Protocol 4.0: All patients >=19 years of age who receive an FDA-approved durable MCSD* implanted at an INTERMACS(RegisteredTM)-activated hospital. (NOTE: Patients implanted before the hospital activation date are not eligible for participation in INTERMACS(RegisteredTM)