Heart FailureNCT02205411
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
A study testing HeartAssist 5® VAD System in people with Heart Failure and Cardiac Failure, run by ReliantHeart Inc. at 14 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Failure, Congestive Heart Failure
- What is being tested?
- HeartAssist 5® VAD System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to sign Informed Consent.
- Age ≥ 18
- Body Surface Area (BSA) ≥ 1.2 m2.
- 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
- LVAD implantation has been approved by the institution's multidisciplinary transplant committee.
- Patient is NYHA Class IV.
- Able to return to the clinical site for all routine follow up visits.
Who cannot join
- Cardiothoracic surgery within 30 days prior to enrollment.
- Acute Myocardial Infarction within 14 days prior to enrollment.
- Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty or left ventricular assist device.
- Mechanical, animal, or human tissue heart valve.
- History of untreated abdominal or thoracic aortic aneurysm > 5 cm.
- On ventilator support for > 72 hours within four days immediately prior to enrollment.
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- Ongoing mechanical circulatory support other than an intra-aortic balloon pump (IABP).
- Proven history of pulmonary embolism within 90 days of enrollment.
- Moderate to severe aortic insufficiency as determined by echocardiogram without plans for correction during pump implantation surgery.
- Requires aortic, mitral, tricuspid or pulmonary valve replacements (including Bioprosthetic valves) or left ventricular (LV) aneurysm resection.
- 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)
- 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.
- Significant renal dysfunction defined as > 3.5 mg/dl or requires hemo or peritoneal dialysis for renal failure (excluding ultra-filtration for fluid removal).
- 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.
- Pregnancy
- 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.
- 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
- Modified Rankin Scale score of ≥ 2 or has any neurologic disability as confirmed by imaging (CT or MRI).
- Significant lower extremity peripheral vascular disease accompanied by rest pain or leg ulceration.
- 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.
- Psychiatric disorder, or other psychosocial behavior that is likely to impair compliance with the study protocol.
- Receiving therapy with an investigational intervention or participating in any other clinical investigation at the time of enrollment.
- Condition, other than heart failure, that may limit survival to less than three (3) years and/or would exclude cardiac transplantation.
- Unwilling or unable to comply with any study requirement.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Miami
Coral Gables, Florida, 33146
CHI St. Luke's Baylor College of Medicine Medical Center
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
University of Texas Health Science Center
Houston, Texas, 77030
Indiana University Health, Inc. d/b/a Methodist Research Institute
Indianapolis, Indiana, 46202
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, 46260
Jewish Hospital
Louisville, Kentucky, 40202
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Hospital - Saint Mary's Campus
Rochester, Minnesota, 55905
University of California San Francisco
San Francisco, California, 94143
Providence Sacred Heart Hospital
Spokane, Washington, 99204
University of Stanford
Stanford, California, 94305
About this study
Official title: A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the HeartAssist 5® VAD System Compared to the Thoratec HeartMate II® VAD and HeartWare® HVAD for Left Ventricular Support in Patients Awaiting Cardiac Transplantation
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.
Read the detailed 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.
- Being tested
- HeartAssist 5® VAD System, Control VAD
- Keywords
- heart assist device, ventricular assist device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartAssist 5® VAD SystemDevice
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 VADDevice
The HeartMate II® VAD or HVAD®
| Study group | Role | What they receive |
|---|---|---|
| HeartAssist 5® VAD System | Experimental | Implant of the HeartAssist 5® VAD System Receives: Device: HeartAssist 5® VAD System |
| Control VAD | Active comparator | Not described Receives: Device: Control VAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Secondary outcomes (4)
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.
Measured: 180 days
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.
Measured: 180 days
Functional Status
NYHA and six-minute walk analysis will be reported by group for data at pre-implant and at study-defined intervals.
Measured: 180 days
Neurologic Status
Evaluation of any change in Modified Rankin Scale from baseline to 180-days post-implant or device explant.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: Inability to timely enroll.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReliantHeart Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205411
- Sponsor's protocol ID
- CAP00030
- Status last verified
- Mar 2018
- First submitted
- 24 Jul 2014
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the HeartAssist 5® VAD System Compared to the Thoratec HeartMate II® VAD and HeartWare® HVAD for Left Ventricular Support in Patients Awaiting Cardiac Transplantation
- ClinicalTrials.gov ID
- NCT02205411
- Acronym / sponsor ID
- CAP00030
- Keywords
- heart assist device, ventricular assist device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to timely enroll.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- ReliantHeart Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartAssist 5® VAD System | Experimental | Device: HeartAssist 5® VAD SystemImplant of the HeartAssist 5® VAD System |
| Control VAD | Active comparator | Device: Control VAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to sign Informed Consent.
- Age ≥ 18
- Body Surface Area (BSA) ≥ 1.2 m2.
- 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
- LVAD implantation has been approved by the institution's multidisciplinary transplant committee.
Key exclusion criteria (24 listed)
- Cardiothoracic surgery within 30 days prior to enrollment.
- Acute Myocardial Infarction within 14 days prior to enrollment.
- Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty or left ventricular assist device.
- Mechanical, animal, or human tissue heart valve.
- History of untreated abdominal or thoracic aortic aneurysm > 5 cm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartAssist 5® VAD SystemThe 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. | Device | HeartAssist 5® VAD System |
| Control VADThe HeartMate II® VAD or HVAD® | Device | Control VAD |
Primary outcome
The primary endpoint is success at 180 days
Time frame: 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.
4 secondary outcomes
Adverse Events
Time frame: 180 days
Quality of Life
Time frame: 180 days
Functional Status
Time frame: 180 days
Neurologic Status
Time frame: 180 days
Results and safety
The study was stopped early (reason given: Inability to timely enroll.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartAssist 5® VAD System in people with Heart Failure and Cardiac Failure, run by ReliantHeart Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inability to timely enroll.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is success at 180 days (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.