Refractory Heart FailureNCT01001793
Levacor™ Ventricular Assist Device (VAD) Bridge to Transplant Study
A study testing Levacor Ventricular Assist Device in people with Refractory Heart Failure, run by World Heart Corporation at 6 sites in United States.
Trial summary
The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant (BTT) in cardiac transplant candidates with presumed non-reversible left ventricular failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Heart Failure
- What is being tested?
- Levacor Ventricular Assist Device
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2009to Jul 2011
- 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
- Patient must be at least 18 years of age at the time of VAD implantation.
- Listed for cardiac transplantation as UNOS Status 1A or 1B at the time of VAD implantation or within 72 hours of VAD implantation.
- Body Surface Area (BSA) 1.2 m2 or greater.
- If female of childbearing potential must have negative pregnancy test.
- Patient has signed an Informed Consent.
Who cannot join
- Unacceptable surgical risk according to Principal Investigator.
- Intolerance or contraindication to anticoagulation or antiplatelet therapies.
- Excessive risk of bleeding as evidenced by INR > 2.3, or PTT > 45 sec, or platelet count < 50,000 U, unresponsive to treatment.
- Excessive neurologic risk documented as TIA within the last 3 months or stroke within the last 6 months.
- Evidence of any of the following indicators of end-organ dysfunction: total bilirubin > 4 mg/dL, ALT/AST > 3 times upper limit normal, serum creatinine >3.5 mg/dL.
- Fixed pulmonary hypertension with a most recent PVR > 5 Wood units unresponsive to pharmacological intervention.
Show all 18Show fewer
- Severe chronic obstructive pulmonary disease as evidenced by an FEV1 < 1.0 L or restrictive lung disease or prolonged (> 48 hours) intubation.
- Presence of mechanical aortic valve that will not be converted to a bioprosthesis during VAD implantation.
- Planned concomitant surgical procedures other than aortic valve repair or tissue valve placement to treat moderate to severe aortic insufficiency, tricuspid valve repair, mitral valve repair, critical lesion CABG, LV thrombectomy (apical), closure of persistent foramen ovale, atrial septal defect.
- Cardiogenic shock secondary to acute myocardial infarction.
- Presence of ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
- Presence of uncontrolled infection.
- BMI > 40 kg/m2.
- Significant peripheral vascular disease accompanied by pain at rest, extremity ulceration or disabling claudication.
- Illness, other than heart disease, that would limit survival to less than 1 year.
- Pulmonary embolus < 2 weeks before VAD implant.
- Poor/compromising nutritional status in judgment of Principal Investigator.
- Participation in another clinical trial that, according to the Principal Investigator, is likely to affect the Study outcome or confound the results.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Inova Fairfax Hospital/Inova Heart & Vascular Institute
Falls Church, Virginia, 22042
Jewish Hospital
Louisville, Kentucky, 40202
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
University of Utah Hospital
Salt Lake City, Utah, 84132
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Evaluation of the Levacor™ Ventricular Assist Device as a Bridge to Cardiac Transplantation
The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant (BTT) in cardiac transplant candidates with presumed non-reversible left ventricular failure.
- Conditions
- Refractory Heart Failure
- Being tested
- Levacor 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.
Levacor Ventricular Assist DeviceDevice
Surgical procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Success is defined as any one of the following: survival to cardiac transplantation prior to 180 days, survival on device to 180 days, device removal for recovery and survival to 60 days after device removal
Measured: 6 months
Secondary outcomes (9)
Survival to transplant
Measured: 6 months
Survival 30 days post-transplant
Measured: 6 months
Survival while on device
Measured: 6 months
Incidence of adverse events while on device
Measured: 6 months
Device reliability
Measured: 6 months
Reoperations
Measured: 6 months
Functional status
Measured: 6 months
Quality of life
Measured: 6 months
Neurocognitive evaluation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Commercial considerations relating to required device modifications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Heart Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001793
- Sponsor's protocol ID
- LEV01
- Status last verified
- Sep 2011
- First submitted
- 24 Oct 2009
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Levacor™ Ventricular Assist Device as a Bridge to Cardiac Transplantation
- ClinicalTrials.gov ID
- NCT01001793
- Acronym / sponsor ID
- LEV01
- Conditions
- Refractory Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Commercial considerations relating to required device modifications.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- World Heart CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Oct 2009 (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 Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant (BTT) in cardiac transplant candidates with presumed non-reversible left ventricular failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must be at least 18 years of age at the time of VAD implantation.
- Listed for cardiac transplantation as UNOS Status 1A or 1B at the time of VAD implantation or within 72 hours of VAD implantation.
- Body Surface Area (BSA) 1.2 m2 or greater.
- If female of childbearing potential must have negative pregnancy test.
- Patient has signed an Informed Consent.
Key exclusion criteria (18 listed)
- Unacceptable surgical risk according to Principal Investigator.
- Intolerance or contraindication to anticoagulation or antiplatelet therapies.
- Excessive risk of bleeding as evidenced by INR > 2.3, or PTT > 45 sec, or platelet count < 50,000 U, unresponsive to treatment.
- Excessive neurologic risk documented as TIA within the last 3 months or stroke within the last 6 months.
- Evidence of any of the following indicators of end-organ dysfunction: total bilirubin > 4 mg/dL, ALT/AST > 3 times upper limit normal, serum creatinine >3.5 mg/dL.
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 |
|---|---|---|
| Levacor Ventricular Assist DeviceSurgical procedure | Device | – |
Primary outcome
Success is defined as any one of the following: survival to cardiac transplantation prior to 180 days, survival on device to 180 days, device removal for recovery and survival to 60 days after device removal
Time frame: 6 months
9 secondary outcomes
Survival to transplant
Time frame: 6 months
Survival 30 days post-transplant
Time frame: 6 months
Survival while on device
Time frame: 6 months
Incidence of adverse events while on device
Time frame: 6 months
Device reliability
Time frame: 6 months
Reoperations
Time frame: 6 months
Functional status
Time frame: 6 months
Quality of life
Time frame: 6 months
Neurocognitive evaluation
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Commercial considerations relating to required device modifications.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2011.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levacor Ventricular Assist Device in people with Refractory Heart Failure, run by World Heart Corporation at 6 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 5 inclusion and 18 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 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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: Commercial considerations relating to required device modifications.). 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?
Success is defined as any one of the following: survival to cardiac transplantation prior to 180 days, survival on device to 180 days, device removal for recovery and survival to 60 days after device removal (time frame: 6 months). 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 23 Dec 2011.