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

Heart Failure Clinical Trial

— COMPETENCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01187368
• Other study ID #: 020-1601-001-P01
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2023
• Source: Evaheart, Inc.
• Contact: Lizatte Martinez
• Phone: 713-520-7979
• Email: lmartinez[@]evaheart-usa.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Adult (>18 years old), advanced heart failure NYHA Class III with dyspnea upon mild physical activity or Class IV patients who are refractory to advanced heart failure management and meet study Inclusion/Exclusion criteria will be enrolled.

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 advanced heart failure.

Subjects will be followed for 6 months (short-term cohort) and 24 months (long-term cohort) after EVA2/HM3 LVAS implantation or until outcome events of transplantation, explantation, death or withdrawal, whichever occurs first. Whereas subjects experiencing the outcome events of "Severe RHF" and "Disabling stroke" will remain in study follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 399
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy

2. Technical obstacles which pose an inordinately high surgical risk

3. Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5

4. Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L.

5. Positive pregnancy test if of childbearing potential

6. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis

7. History of any organ transplant

8. Platelet count <100,000/mL

9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues

10. History of confirmed, untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment

11. Presence of an active, uncontrolled infection

12. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy that the investigator will require based upon the patient's health status

13. Presence of remarkable pre-defined end-organ dysfunction.

14. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant

15. Low albumin - removed from recent exclusion criteria

16. Planned Bi-VAD support prior to enrollment

17. Patient has known hypo- or hyper coagulable state such as disseminated intravascular coagulation and heparin induced thrombocytopenia (HIT)

18. Participation in any other clinical investigation that is likely to confound study results or affect the study

19. Any condition other than heart failure that could limit survival to less than 24 months

20. Patients refusing blood transfusion

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• EVAHEART Left Ventricular Assist System (LVAS)
Three-hundred and ninety-nine (399) subjects will be enrolled and randomized in a 2:1 assignment to receive EVA2 or the comparator device, HeartMate 3.
• HeartMate 3
Three-hundred and ninety-nine (399) subjects will be enrolled and randomized in a 2:1 assignment to receive EVA2 or the comparator device, HeartMate 3.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Atrium Health Sanger Heart and Vascular Institute	Charlotte	North Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	The Christ Hospital	Cincinnati	Ohio
United States	Baylor Scott and White, Dallas	Dallas	Texas
United States	UF Health Shands Hospital	Gainesville	Florida
United States	Penn State Health Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	St. Vincent Hospital Indianapolis	Indianapolis	Indiana
United States	University of Louisville	Louisville	Kentucky
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Jackson Health Systems Jackson Memorial Hospital Lbn Public Health Trust of Miami Dade County Florida	Miami	Florida
United States	Temple University	Philadelphia	Pennsylvania
United States	Methodist Hospital - San Antonio	San Antonio	Texas
United States	University of Washington Medical Center	Seattle	Washington
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Evaheart, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Powered Secondary Endpoint: GI bleeding	Documented mucosal (GI tract and/or nasopharynx) bleeding, requiring blood transfusion (backed red blood cells) or hemoglobin drop (>2 g/dL) without another identifiable source of bleeding AND meet one or more of the following: Identified mucosal bleeding by endoscope; Appearance of overt melena, hematochezia, hematemesis, epistaxis; Occult bleeding as evidenced by hemoccult-positive stool (2 consecutive testing to avoid false positive)	24 months
Primary	Short-Term Primary Endpoint	Survival to cardiac transplant or device explant for recovery free from disabling stroke (Modified Rankin Score > 3) or pre-defined severe Right Heart Failure at 6 months after implantation of the originally implanted device	6 months
Primary	Long-Term Primary Endpoint	Survival to cardiac transplant or device explant for recovery free from disabling stroke (Modified Rankin Score > 3) or pre-defined severe Right Heart Failure at 24 months after implantation of the originally implanted device	24 months
Secondary	Change in KCCQ and EuroQol		Baseline versus POD 30, 90, 180, 360 and every 180 days
Secondary	Change in 6-minute walk test		Baseline versus POD 30, 90, 180, 360 and every 180 days
Secondary	NYHA functional class		Baseline versus POD 30, 90, 180, 360, and every 180 days
Secondary	Frequency and incidence of all re-operations		Discharge after implant through transplant or explant for recovery.
Secondary	Frequency and incidence of all rehospitalizations		Discharge after implant through transplant or explant for recovery.
Secondary	Incidence of adverse events, serious adverse events and UADEs	Peri-operative complications and any failure to successfully implant the device.; All adverse events occurring during the acute and chronic phase of the study (frequency, severity, duration, sequelae and relationship to device).; All adverse events occurring during the extension phase (frequency, severity, duration, sequelae and relationship to device).	Implant through transplant or explant for recovery (+60 days or discharge) or 180 days on device; then duration of device support, up to 360 days (approximate)
Secondary	Incidence of all device failures and device malfunctions		Implant through transplant or explant for recovery (+60 days or discharge) or 180 days on device; then duration of device support, up to 360 days(approximate)
Secondary	Post-transplant or post-explant survival		Up to 30 days post-transplant or post-explant