LVAD (Left Ventricular Assist Device) Driveline InfectionNCT04153786
Effect of Cardiac Resynchronization Therapy (CRT) on Left Ventricular Assist Device (LVAD) Function
A study testing Temporary changes in an already-implanted medical device (biventricular pacemaker) in people with LVAD (Left Ventricular Assist Device) Driveline Infection, run by University of California, Davis at 1 site in United States.
Trial summary
Certain patients with congestive heart failure are treated both by implantation of an LVAD, as well as implantation with a biventricular pacemaker. Both of these devices, individually, have been shown to improve the health of patients with heart failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- LVAD (Left Ventricular Assist Device) Driveline Infection
- What is being tested?
- Temporary changes in an already-implanted medical device (biventricular pacemaker)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2019to 7 Nov 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients who have undergone implantation of both a biventricular pacemaker and LVAD who are at least three months post-LVAD implantation and who receive routine follow-up care at the UC Davis / UC San Diego Adult Arrhythmia/ Device/ LVAD clinic.
- Potential enrollees have been directly identified by their existing medical providers in clinic, who are investigators in this study.
Who cannot join
- Any patients who do not present to their routine follow-up appointment at the time of this study.
- Any patients who have undergone LVAD placement less than three months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
Certain patients with congestive heart failure are treated both by implantation of an LVAD, as well as implantation with a biventricular pacemaker. Both of these devices, individually, have been shown to improve the health of patients with heart failure. However, only a small number of patients have both an LVAD and a biventricular pacemaker at the same time.
Pacemakers have many different settings. However, there is little data to inform physicians which of these different settings is best for the flow of an LVAD. This study is evaluating patients who have both a biventricular pacemaker and an LVAD. Investigators will operate the pacemaker at multiple different settings and monitor the LVAD's function to determine which, if any, setting is best for the LVAD's flow.
Read the detailed description
Cardiac resynchronization therapy (CRT) with a biventricular pacemaker has been well-validated to improve symptoms and reduce death in select patients with heart failure. In healthy adults, the two chambers of the heart which pump blood throughout the body (the left and right ventricles) activate and contract together in synchronous fashion. In certain patients with heart failure (specifically, those with a reduced ejection fraction), the left and right ventricles no longer activate and contract synchronously. CRT restores ventricular synchrony by simultaneously activating the left (LV) and right ventricles (RV) with electrical pacing.
Left ventricular assist devices (LVADs) are used to provide mechanical support to patients with more advanced, often end-stage, heart failure. In these cases, the heart's ventricles function so poorly that even despite all standard therapies (including CRT), patients experience symptoms of congestive heart failure even at rest. The LVAD suctions blood from the ventricle and propels it into the aorta, offloading the ventricle and assisting its function.
Due to the similar reasons for using each therapy, a number of patients already possess a biventricular pacemaker at the time of LVAD implantation. Individually, each intervention is known to improve both patient survival and functional status. However, there is sparse data to evaluate the effectiveness of using both devices simultaneously. Specifically, no data is yet available assessing the effect of CRT on the functional parameters of the LVAD.
This protocol will operate the biventricular pacemaker at various settings and assess for changes in the LVAD's function in response to those settings. "Fine-tuning" and identifying the ideal the pacemaker settings will maximize clinical benefit in patients with both devices.
- Being tested
- Temporary changes in an already-implanted medical device (biventricular pacemaker)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary changes in an already-implanted medical device (biventricular pacemaker)Other
During the patient's routine clinic visit, investigators will adjust the patient's pacemaker to four different settings and monitor for any changes in the function of the LVAD.
The pacemaker will be set to each new setting for 2-5 minutes. After this, the pacemaker will be returned to its original / pre-existing setting, and the patient will leave the clinic with no overall changes to the settings of either the pacemaker or LVAD.
However, if investigators find that one of the four pacemaker settings results in a clear improvement in the LVAD function, the patient will be given the option of resetting their pacemaker to that new setting before leaving the clinic. In either case, the LVAD settings will not be altered at all. The adjustments will be made by the regular device staff who routinely see the patients and maintain their devices during their regular follow-up clinic visits.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Pacemakers will be programmed to BiV pacing, left ventricular (LV) pacing, right ventricular (RV) pacing and no pacing for five minutes each. LVAD flow will be recorded every thirty seconds for five minutes with each setting. Once the interventions have been completed, all pacemakers will be returned to their original setting. Receives: Other: Temporary changes in an already-implanted medical device (biventricular pacemaker) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVAD flow
Flow is the liters per minute (L/min) of blood moved by the device.
Measured: 2-5 minutes
LVAD power
Power is the voltage required by the device over each cardiac cycle.
Measured: 2-5 minutes
LVAD speed
LVAD speed, or revolutions per minute (RPMs) of the device, is set by providers to a fixed value.
Measured: 2-5 minutes
LVAD pulsatility index (PI)
LVAD PI reflects the contribution of the native heart's cardiac output (or "pulse") on pump flow
Measured: 2-5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start2 Nov 2019
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Why it stopped: Study stopped due to PI's failure to adhere to IRB reporting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LVAD (Left Ventricular Assist Device) Driveline InfectionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Uma Srivatsa, MD, Principal investigator, UC DavisMartin Cadeiras, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153786
- Sponsor's protocol ID
- 1403080
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2019
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cardiac Resynchronization Therapy (CRT) on Left Ventricular Assist Device (LVAD) Function
- ClinicalTrials.gov ID
- NCT04153786
- Acronym / sponsor ID
- 1403080
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to PI's failure to adhere to IRB reporting.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 6 Nov 2019 (actual)
- 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.
Certain patients with congestive heart failure are treated both by implantation of an LVAD, as well as implantation with a biventricular pacemaker. Both of these devices, individually, have been shown to improve the health of patients with heart failure. However, only a small number of patients have both an LVAD and a biventricular pacemaker at the same time.
Pacemakers have many different settings. However, there is little data to inform physicians which of these different settings is best for the flow of an LVAD. This study is evaluating patients who have both a biventricular pacemaker and an LVAD. Investigators will operate the pacemaker at multiple different settings and monitor the LVAD's function to determine which, if any, setting is best for the LVAD's flow.
Detailed description
Cardiac resynchronization therapy (CRT) with a biventricular pacemaker has been well-validated to improve symptoms and reduce death in select patients with heart failure. In healthy adults, the two chambers of the heart which pump blood throughout the body (the left and right ventricles) activate and contract together in synchronous fashion. In certain patients with heart failure (specifically, those with a reduced ejection fraction), the left and right ventricles no longer activate and contract synchronously. CRT restores ventricular synchrony by simultaneously activating the left (LV) and right ventricles (RV) with electrical pacing.
Left ventricular assist devices (LVADs) are used to provide mechanical support to patients with more advanced, often end-stage, heart failure. In these cases, the heart's ventricles function so poorly that even despite all standard therapies (including CRT), patients experience symptoms of congestive heart failure even at rest. The LVAD suctions blood from the ventricle and propels it into the aorta, offloading the ventricle and assisting its function.
Due to the similar reasons for using each therapy, a number of patients already possess a biventricular pacemaker at the time of LVAD implantation. Individually, each intervention is known to improve both patient survival and functional status. However, there is sparse data to evaluate the effectiveness of using both devices simultaneously. Specifically, no data is yet available assessing the effect of CRT on the functional parameters of the LVAD.
This protocol will operate the biventricular pacemaker at various settings and assess for changes in the LVAD's function in response to those settings. "Fine-tuning" and identifying the ideal the pacemaker settings will maximize clinical benefit in patients with both devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Other: Temporary changes in an already-implanted medical device (biventricular pacemaker)Pacemakers will be programmed to BiV pacing, left ventricular (LV) pacing, right ventricular (RV) pacing and no pacing for five minutes each. LVAD flow will be recorded every thirty seconds for five minutes with each setting. Once the interventions have been completed, all pacemakers will be returned to their original setting. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients who have undergone implantation of both a biventricular pacemaker and LVAD who are at least three months post-LVAD implantation and who receive routine follow-up care at the UC Davis / UC San Diego Adult Arrhythmia/ Device/ LVAD clinic.
- Potential enrollees have been directly identified by their existing medical providers in clinic, who are investigators in this study.
Key exclusion criteria (2 listed)
- Any patients who do not present to their routine follow-up appointment at the time of this study.
- Any patients who have undergone LVAD placement less than three months prior to 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 |
|---|---|---|
| Temporary changes in an already-implanted medical device (biventricular pacemaker)During the patient's routine clinic visit, investigators will adjust the patient's pacemaker to four different settings and monitor for any changes in the function of the LVAD. The pacemaker will be set to each new setting for 2-5 minutes. After this, the pacemaker will be returned to its original / pre-existing setting, and the patient will leave the clinic with no overall changes to the settings of either the pacemaker or LVAD. However, if investigators find that one of the four pacemaker settings results in a clear improvement in the LVAD function, the patient will be given the option of resetting their pacemaker to that new setting before leaving the clinic. In either case, the LVAD settings will not be altered at all. The adjustments will be made by the regular device staff who routinely see the patients and maintain their devices during their regular follow-up clinic visits. | Other | Cohort |
Primary outcome
LVAD flow
Time frame: 2-5 minutes
Flow is the liters per minute (L/min) of blood moved by the device.
LVAD power
Time frame: 2-5 minutes
Power is the voltage required by the device over each cardiac cycle.
LVAD speed
Time frame: 2-5 minutes
LVAD speed, or revolutions per minute (RPMs) of the device, is set by providers to a fixed value.
LVAD pulsatility index (PI)
Time frame: 2-5 minutes
LVAD PI reflects the contribution of the native heart's cardiac output (or "pulse") on pump flow
Results and safety
The study was stopped early (reason given: Study stopped due to PI's failure to adhere to IRB reporting.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for LVAD (Left Ventricular Assist Device) Driveline Infection
Enrolling by invitationObservational study
Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device
LVAD (Left Ventricular Assist Device) Driveline Infection
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.
Uma Srivatsa, MD principal investigator
UC Davis
Martin Cadeiras, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary changes in an already-implanted medical device (biventricular pacemaker) in people with LVAD (Left Ventricular Assist Device) Driveline Infection, run by University of California, Davis 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 2 inclusion and 2 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 7 Nov 2024. 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?
The study was stopped early (reason given: Study stopped due to PI's failure to adhere to IRB reporting.). 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?
LVAD flow (time frame: 2-5 minutes). The study lists 4 primary outcomes in all. 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 7 Nov 2024.