Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System: the COMPETENCE Trial

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• The following is a list of general inclusion criteria:

• Age ≥ 18 years

• Left Ventricular Ejection Fraction (LVEF) < 30%

• NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure

• Inotrope dependent OR Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes

• Patient is able to provide written informed consent

• More detailed inclusion criteria information is noted in the study protocol

Locations
United States
Florida
UF Health Shands Hospital
Recruiting
Gainesville
Indiana
St. Vincent Hospital Indianapolis
Recruiting
Indianapolis
Kentucky
University of Louisville
Recruiting
Louisville
Massachusetts
Tufts Medical Center
Recruiting
Boston
North Carolina
Atrium Health Sanger Heart and Vascular Institute
Active, not recruiting
Charlotte
Ohio
The Christ Hospital
Recruiting
Cincinnati
Pennsylvania
Penn State Health Milton S Hershey Medical Center
Recruiting
Hershey
Temple University
Recruiting
Philadelphia
Texas
Baylor Scott and White, Dallas
Recruiting
Dallas
Baylor College of Medicine
Recruiting
Houston
Methodist Hospital - San Antonio
Active, not recruiting
San Antonio
Virginia
University of Virginia Medical Center
Recruiting
Charlottesville
Washington
University of Washington Medical Center
Recruiting
Seattle
Wisconsin
University of Wisconsin-Madison
Recruiting
Madison
Contact Information
Primary
Lizatte Martinez
lmartinez@evaheart-usa.com
713-520-7979
Backup
Maricar Cruz
maricar@evaheart-usa.com
713-520-7979
Time Frame
Start Date: March 31, 2020
Estimated Completion Date: March 31, 2024
Participants
Target number of participants: 399
Treatments
Experimental: Evaheart LVAS (EVA2)
The objective of the study is to evaluate the safety and effectiveness of the EVA2 by demonstrating non-inferiority to commercially approved LVADs when used for the treatment of refractory NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure.
Active Comparator: HeartMate 3 (HM3)
The objective of the study is to evaluate the safety and effectiveness of the EVA2 by demonstrating non-inferiority to commercially approved LVADs when used for the treatment of refractory NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure.
Related Therapeutic Areas
Sponsors
Leads: Evaheart, Inc.

This content was sourced from clinicaltrials.gov

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