Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System
Public ClinicalTrials.gov record NCT01187368. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System: the COMPETENCE Trial
Study identification
- NCT ID
- NCT01187368
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Evaheart, Inc.
- Industry
- Enrollment
- 399 participants
Conditions and interventions
Conditions
Interventions
- EVAHEART Left Ventricular Assist System (LVAS) Device
- HeartMate 3 Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 30, 2020
- Primary completion
- Jul 30, 2027
- Completion
- Jul 30, 2028
- Last update posted
- Mar 26, 2026
2020 – 2028
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UF Health Shands Hospital | Gainesville | Florida | 32608 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| St. Vincent Hospital Indianapolis | Indianapolis | Indiana | 46260 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Penn State Health Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Baylor Scott and White, Dallas | Dallas | Texas | 75246 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Methodist Hospital - San Antonio | San Antonio | Texas | 78229 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01187368, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2026 · Synced May 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01187368 live on ClinicalTrials.gov.