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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02205411
Other study ID # CAP00030
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date March 2018

Study information

Verified date March 2018
Source ReliantHeart Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.


Description:

The HeartAssist 5® VAD System is intended for use as a bridge to heart transplantation and will be compared to the HeartMate II and HVAD devices.

Patients that meet the study criteria will be randomized 1:1 to either the HeartAssist 5® VAD System (treatment group) or control group (HeartMate II and HVAD). The physician will have the option to choose which control device to implant.

The primary objective of the study is to show non-inferiority of the HeartAssist 5® (treatment group) to the control group.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Able to sign Informed Consent.

2. Age = 18

3. Body Surface Area (BSA) = 1.2 m2.

4. Cardiac transplant candidate, defined as: Listed for cardiac transplant, and designated by the institution's multidisciplinary transplant committee as appropriate forLVAD Bridge-to-Transplantation therapy, or Designated by the institutions's multidisciplinary transplant committee as: 1) an appropriate candidate for LVAD Bridge-to transplant therapy, and 2) An inappropriate candidate for LVAD destination therapy

5. LVAD implantation has been approved by the institution's multidisciplinary transplant committee.

6. Patient is NYHA Class IV.

7. Able to return to the clinical site for all routine follow up visits.

Exclusion Criteria:

1. Cardiothoracic surgery within 30 days prior to enrollment.

2. Acute Myocardial Infarction within 14 days prior to enrollment.

3. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty or left ventricular assist device.

4. Mechanical, animal, or human tissue heart valve.

5. History of untreated abdominal or thoracic aortic aneurysm > 5 cm.

6. On ventilator support for > 72 hours within four days immediately prior to enrollment.

7. Ongoing mechanical circulatory support other than an intra-aortic balloon pump (IABP).

8. Proven history of pulmonary embolism within 90 days of enrollment.

9. Moderate to severe aortic insufficiency as determined by echocardiogram without plans for correction during pump implantation surgery.

10. Requires aortic, mitral, tricuspid or pulmonary valve replacements (including Bioprosthetic valves) or left ventricular (LV) aneurysm resection.

11. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelets <100,000, INR > 1.6 or PTT > 2.5 times control in the absence of anticoagulation therapy)

12. Severe right ventricular failure as defined by the anticipated need for right ventricular assist device (RVAD) support OR extracorporeal membrane oxygenation (ECMO) at the time of implantation OR right atrial pressure > 20 mmHg while on multiple inotropes.

13. Significant renal dysfunction defined as > 3.5 mg/dl or requires hemo or peritoneal dialysis for renal failure (excluding ultra-filtration for fluid removal).

14. Evidence of intrinsic hepatic disease defined as liver enzyme values (AST, ALT and LDH that are > 3 times the upper limit of normal) OR a total bilirubin > 3 mg/dl OR biopsy proven liver cirrhosis or portal hypertension.

15. Pregnancy

16. Active systemic infection prior to study enrollment not yet resolved by treatment. Active Systemic Infection is defined by any one of the following in spite of antibiotic, antiviral or antifungal treatment: 2 or more consecutive positive cultures; elevated temperature > 37.2 (°C) and white blood cell count > 11.0 (103/ml); hypotension, tachycardia and generalized malaise.

17. Stroke within 90 days prior to enrollment OR patient has a history of cerebral vascular disease with > 80% extra cranial stenosis documented by carotid Doppler study during transplant evaluation

18. Modified Rankin Scale score of = 2 or has any neurologic disability as confirmed by imaging (CT or MRI).

19. Significant lower extremity peripheral vascular disease accompanied by rest pain or leg ulceration.

20. Intolerant to anticoagulant or antiplatelet therapies or any other peri- or postoperative therapy that the investigator may administer based upon the patient's health status.

21. Psychiatric disorder, or other psychosocial behavior that is likely to impair compliance with the study protocol.

22. Receiving therapy with an investigational intervention or participating in any other clinical investigation at the time of enrollment.

23. Condition, other than heart failure, that may limit survival to less than three (3) years and/or would exclude cardiac transplantation.

24. Unwilling or unable to comply with any study requirement.

Study Design


Intervention

Device:
HeartAssist 5® VAD System
The HeartAssist 5® VAD System is a small, implantable pump that is designed to increase blood flow for patients who have heart failure. The device is intended to support patients in the hospital or at home.
Control VAD
The HeartMate II® VAD or HVAD®

Locations

Country Name City State
United States University of Chicago Medical Center Chicago Illinois
United States University of Miami Coral Gables Florida
United States CHI St. Luke's Baylor College of Medicine Medical Center Houston Texas
United States Houston Methodist Hospital Houston Texas
United States University of Texas Health Science Center Houston Texas
United States Indiana University Health, Inc. d/b/a Methodist Research Institute Indianapolis Indiana
United States St. Vincent Hospital & Health Care Center Indianapolis Indiana
United States Jewish Hospital Louisville Kentucky
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States University of Pennsylvania Philadelphia Pennsylvania
United States Mayo Clinic Hospital - Saint Mary's Campus Rochester Minnesota
United States University of California San Francisco San Francisco California
United States Providence Sacred Heart Hospital Spokane Washington
United States University of Stanford Stanford California

Sponsors (1)

Lead Sponsor Collaborator
ReliantHeart Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint is success at 180 days Success at 180 days is defined as alive on the original device, transplanted or explanted for heart recovery and alive 60 days after device explant. 180 days
Secondary Adverse Events Device safety will be reported as the frequency of each adverse event, (including device failure, device malfunction or unanticipated adverse device effects) and the rate of adverse events per patient year. 180 days
Secondary Quality of Life Quality of life data, as measured by the EuroQol (EQ-5D) will be summarized and analyzed, for both groups, comparing data at baseline and study intervals. 180 days
Secondary Functional Status NYHA and six-minute walk analysis will be reported by group for data at pre-implant and at study-defined intervals. 180 days
Secondary Neurologic Status Evaluation of any change in Modified Rankin Scale from baseline to 180-days post-implant or device explant. 180 days
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