Heart FailureLVAD-ON-OFFNCT04219618
The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study
A study testing Off-Pump and On-Pump in people with Heart Failure and LVAD, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, LVAD
- What is being tested?
- Off-Pump and On-Pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient has had a diagnosis of end stage heart failure, New York Heart association (NYHA) class III or IV HF for a minimum of 90 days prior to screening.
- The patient has guideline-directed medical therapy according to American College of Cardiology(ACC)/American Heart Association (AHA)/European Society of Cardiology(ESC) heart failure(HF) guidelines
- The patient has an Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score of 1-3.
- Left ventricular assist device (LVAD) placement is intended as a bridge to transplant (BTT) or destination therapy (DT) with either HeartWare Ventricular Assist Device (HVAD) or HeartMate III LVAD.
- The patient is able to sign informed consent form and Release of Medical Information Form.
- The patients is willing and able to participate in scheduled follow-up appointments.
Who cannot join
- The patient requires concomitant surgery for left ventricular or atrial appendage closure or the patient has severe aortic insufficiency, mitral stenosis, or severe tricuspid regurgitation.
- The patient has an intracardiac thrombus or other mass diagnosed by echocardiography, left ventriculogram, or other imaging.
- Planned insertion of right ventricular(RV) support device (either temporary or permanent).
- The patient has suffered an acute cardiovascular event such as acute coronary syndrome (ST elevation myocardial infarction (STEMI) or Non-ST elevation myocardial infarction (NSTEMI), or unstable angina, or underwent any cardiac surgery or interventional cardiac or peripheral vascular procedure within 30 days prior to LVAD implantation.
- The patient has had ischemic or hemorrhagic stroke as diagnosed by CT or MRI within 90 days prior to study enrollment.
- The patient had prior heart or other organ transplantation, or surgically implanted LVAD or cardiac shunt.
Show all 15Show fewer
- The patient will likely need an immediate heart transplant due to hemodynamic instability.
- The patient has had a known active malignancy or treatment for cancer within the past year except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer that has been definitively treated.
- The patient has history of any malignancy where expected survival is less than two years. Past medical history of cancer is not exclusionary as long as subject has been disease-free for at least one years since the time of diagnosis and treatment.
- Patient has a severe co-morbidity (current need for hemodialysis or current glomerular filtration rate(GFR) ≤20 mL/minute/1.73 m2 estimated by Modification of Diet in Renal Disease( MDRD)calculation; hepatic impairment defined as liver function tests [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)] >3x Upper Limit of Normal within 30 days prior to LVAD implantation or known objectively confirmed intrinsic liver disease (e.g., cirrhosis, chronic hepatitis B or hepatitis C virus infection)).
- The patient has a known bleeding diathesis or thrombocytopenia defined as platelet count <50,000 platelets/μL.
- The patient has peri/postpartum cardiomyopathy, or is a pregnant or lactating woman, or a woman of child-bearing age not using a suitable method of contraception.
- The patient, who in the absence of an Implantable Cardioverter Defibrillator (ICD) (or any implanted device capable of defibrillation), has a history of malignant ventricular arrhythmia or sustained ventricular tachycardia (VT), with sustained VT demonstrated by Q wave R wave S wave (QRS) complexes wider than 120 milliseconds, lasting more than 30 seconds, and with a rate of more than 100 beats per minute on screening ECG or other data supporting this diagnosis.
- Recent history of psychiatric disease, including drug or alcohol abuse, that is likely to impair, in the opinion of the investigator, the subject's ability to comply with protocol-mandated procedures.
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: The Left Ventricular Assist Device Off or On Pump Implantation Study: A Single-center Randomized Trial (LVAD-ON-OFF)
The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.
- Conditions
- Heart Failure, LVAD
- Being tested
- Off-Pump, On-Pump
- Keywords
- LVAD
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-PumpDevice
After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
On-PumpDevice
A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.
| Study group | Role | What they receive |
|---|---|---|
| Off-Pump | Experimental | Not described Receives: Device: Off-Pump |
| On-Pump | Active comparator | Not described Receives: Device: On-Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With the Composite Outcome of Moderate or Severe Right Ventricular (RV) Dysfunction (Perioperative Right Heart Failure), Severe Renal Dysfunction Requiring Renal Replacement Therapy, Thrombotic Complications, or Death From Any Cause
Perioperative right ventricular (RV) failure is defined by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scoring as the need for intravenous inotropes for >14 days post-operatively or a right ventricular assist device (RVAD). RV function will be measured by tricuspid annular plane systolic excursion (TAPSE) values assessed using echocardiography. Additionally, hemodynamic evidence of RV dysfunction will also be collected with: a right-atrial pressure (RAP): pulmonary capillary wedge pressure (PCWP) ratio of ≥ 0.67.
A thrombotic complication is defined as any thromboembolic event (transient ischemic attack or stroke objectively confirmed with computed tomography) or confirmed pump thrombus.
Measured: from time of implantation to 30 days post-implantation
Secondary outcomes (17)
Number of Participants With a Need for Blood Product Transfusion Within 48-hours Post-implantation
Measured: from time of implantation to 48 hours post-implantation
Operative Safety as Indicated by the Number of Participants Who Died Within 30 Days Post-implantation
Measured: from time of implantation to 30 days post-implantation
Operative Safety as Indicated by Chest Tube Output Within 24 Hours of Implantation
Measured: from time of implantation to 24 hours post-implantation
Operative Safety as Indicated by Number of Participants Who Underwent Post-operative Re-exploration for Bleeding
Measured: from time of implantation to 30 days post-implantation
Number of Participants With Allosensitization
Allosensitization is defined as calculated panel reactive antibody (cPRA) greater than 10%.
Measured: 30 days post-implantation
Number of Participants With Allosensitization
Allosensitization is defined as calculated panel reactive antibody (cPRA) greater than 10%.
Measured: 6 months post-implantation
Number of Participants With Allosensitization
Allosensitization is defined as calculated panel reactive antibody (cPRA) greater than 10%.
Measured: 12 months post-implantation
Number of Readmissions for Heart Failure
Measured: from time of implantation to 1 year post-implantation
Overall Hemostatic Potential
Measured: Baseline
Overall Coagulation Potential
Measured: Baseline
Overall Fibrinolytic Potential
Measured: Baseline
Overall Hemostatic Potential
Measured: 48 hours post-implantation
Overall Coagulation Potential
Measured: 48 hours post-implantation
Overall Fibrinolytic Potential
Measured: 48 hours post-implantation
Number of Participants With Major Bleeding
Major bleeding is defined as an episode of suspected internal or external bleeding that results in one or more of the following: death, re-operation, hospitalization, transfusion of red blood cells according to INTERMACS definition.
Measured: 30 days post-implantation
Number of Participants With Major Bleeding
Major bleeding is defined as an episode of suspected internal or external bleeding that results in one or more of the following: death, re-operation, hospitalization, transfusion of red blood cells according to INTERMACS definition.
Measured: 6 months post-implantation
Number of Participants With Major Bleeding
Major bleeding is defined as an episode of suspected internal or external bleeding that results in one or more of the following: death, re-operation, hospitalization, transfusion of red blood cells according to INTERMACS definition.
Measured: 12 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Mar 2020
- Primary completion25 May 2021
- Study completion31 Mar 2022
Why it stopped: The study was stopped because the manufacturer stopped producing the HeartWare LVAD device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Gregoric, The University of Texas Health Science Center, Houston
- Investigators
- Igor D Gregoric, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219618
- Sponsor's protocol ID
- HSC-MS-19-0926
- Acronym
- LVAD-ON-OFF
- Status last verified
- May 2022
- First submitted
- 11 Dec 2019
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Left Ventricular Assist Device Off or On Pump Implantation Study: A Single-center Randomized Trial (LVAD-ON-OFF)
- ClinicalTrials.gov ID
- NCT04219618
- Acronym / sponsor ID
- LVAD-ON-OFF / HSC-MS-19-0926
- Conditions
- Heart Failure, LVAD
- Keywords
- LVAD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped because the manufacturer stopped producing the HeartWare LVAD device.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Posted 27 Jun 2022
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 this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off-Pump | Experimental | Device: Off-Pump |
| On-Pump | Active comparator | Device: On-Pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient has had a diagnosis of end stage heart failure, New York Heart association (NYHA) class III or IV HF for a minimum of 90 days prior to screening.
- The patient has guideline-directed medical therapy according to American College of Cardiology(ACC)/American Heart Association (AHA)/European Society of Cardiology(ESC) heart failure(HF) guidelines
- The patient has an Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score of 1-3.
- Left ventricular assist device (LVAD) placement is intended as a bridge to transplant (BTT) or destination therapy (DT) with either HeartWare Ventricular Assist Device (HVAD) or HeartMate III LVAD.
- The patient is able to sign informed consent form and Release of Medical Information Form.
Key exclusion criteria (15 listed)
- The patient requires concomitant surgery for left ventricular or atrial appendage closure or the patient has severe aortic insufficiency, mitral stenosis, or severe tricuspid regurgitation.
- The patient has an intracardiac thrombus or other mass diagnosed by echocardiography, left ventriculogram, or other imaging.
- Planned insertion of right ventricular(RV) support device (either temporary or permanent).
- The patient has suffered an acute cardiovascular event such as acute coronary syndrome (ST elevation myocardial infarction (STEMI) or Non-ST elevation myocardial infarction (NSTEMI), or unstable angina, or underwent any cardiac surgery or interventional cardiac or peripheral vascular procedure within 30 days prior to LVAD implantation.
- The patient has had ischemic or hemorrhagic stroke as diagnosed by CT or MRI within 90 days prior to study enrollment.
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 |
|---|---|---|
| Off-PumpAfter a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta. | Device | Off-Pump |
| On-PumpA standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated. | Device | On-Pump |
Primary outcome
Number of Participants With the Composite Outcome of Moderate or Severe Right Ventricular (RV) Dysfunction (Perioperative Right Heart Failure), Severe Renal Dysfunction Requiring Renal Replacement Therapy, Thrombotic Complications, or Death From Any Cause
Time frame: from time of implantation to 30 days post-implantation
Perioperative right ventricular (RV) failure is defined by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scoring as the need for intravenous inotropes for >14 days post-operatively or a right ventricular assist device (RVAD). RV function will be measured by tricuspid annular plane systolic excursion (TAPSE) values assessed using echocardiography. Additionally, hemodynamic evidence of RV dysfunction will also be collected with: a right-atrial pressure (RAP): pulmonary capillary wedge pressure (PCWP) ratio of ≥ 0.67. A thrombotic complication is defined as any thromboembolic event (transient ischemic attack or stroke objectively confirmed with computed tomography) or confirmed pump thrombus.
17 secondary outcomes
Number of Participants With a Need for Blood Product Transfusion Within 48-hours Post-implantation
Time frame: from time of implantation to 48 hours post-implantation
Operative Safety as Indicated by the Number of Participants Who Died Within 30 Days Post-implantation
Time frame: from time of implantation to 30 days post-implantation
Operative Safety as Indicated by Chest Tube Output Within 24 Hours of Implantation
Time frame: from time of implantation to 24 hours post-implantation
Operative Safety as Indicated by Number of Participants Who Underwent Post-operative Re-exploration for Bleeding
Time frame: from time of implantation to 30 days post-implantation
Number of Participants With Allosensitization
Time frame: 30 days post-implantation
Number of Participants With Allosensitization
Time frame: 6 months post-implantation
Number of Participants With Allosensitization
Time frame: 12 months post-implantation
Number of Readmissions for Heart Failure
Time frame: from time of implantation to 1 year post-implantation
Overall Hemostatic Potential
Time frame: Baseline
Overall Coagulation Potential
Time frame: Baseline
Overall Fibrinolytic Potential
Time frame: Baseline
Overall Hemostatic Potential
Time frame: 48 hours post-implantation
Overall Coagulation Potential
Time frame: 48 hours post-implantation
Overall Fibrinolytic Potential
Time frame: 48 hours post-implantation
Number of Participants With Major Bleeding
Time frame: 30 days post-implantation
Number of Participants With Major Bleeding
Time frame: 6 months post-implantation
Number of Participants With Major Bleeding
Time frame: 12 months post-implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Igor D Gregoric, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Off-Pump and On-Pump in people with Heart Failure and LVAD, run by The University of Texas Health Science Center, Houston at 1 site 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 6 inclusion and 15 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 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 27 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With the Composite Outcome of Moderate or Severe Right Ventricular (RV) Dysfunction (Perioperative Right Heart Failure), Severe Renal Dysfunction Requiring Renal Replacement Therapy, Thrombotic Complications, or Death From Any Cause (time frame: from time of implantation to 30 days post-implantation). 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 27 Jun 2022.