Status:
WITHDRAWN
HVAD(TM) SMART 1.0 Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of HVAD Smart 1.0 study is to collect HVAD device data (i.e., waveform + logfile + pump parameter) in various clinical conditions (e.g., routine follow-up visits, experiencing adverse even...
Eligibility Criteria
Inclusion
- Greater than or equal to 18 years of age:
- Refractory, advanced heart failure patient that is either: Prospectively identified as a candidate to receive the commercial HVAD system as their first durable left Ventricular Assist Device (LVAD) implant for approved indications; or within 10 days of receiving the commercial HVAD system as their first durable LVAD for approved indications
- Patient provides written authorization and/or consent per institution and geographical requirements
Exclusion
- patient who is, or is expected to be inaccessible for follow up
- patient with previous durable mechanical circulatory support device
- patient with planned Bi-VAD procedure
- patient with exclusion criteria required by local law
- patient is currently enrolled in or plans to enroll in an concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness). Concomitant observational studies allowed if permitted by IRB/EC
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 22 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04854200
Start Date
May 1 2021
End Date
August 22 2025
Last Update
August 5 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.