Heart FailureNCT02083419
Cardiac Resynchronization Therapy (CRT) and Left Ventricular Assist Devices (LVAD) Therapy
An observational study of Heart Failure, run by University of Florida at 1 site in United States.
Trial summary
Cardiac resynchronization therapy (CRT) or biventricular pacing is a useful treatment for heart failure and those suffering from arrhythmias. The purpose of this research study is to determine the effect left-ventricular pacing has on patients who have a ventricular assist device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- LVAD CRT
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2014to 2 Feb 2017
- Phase
- Observational
- 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
Study population: Adults with ventricular dysfunction, dyssynchrony, functional capacity presence of arrhythmia. LVAD patients undergo 6 minute walk testing and complete a quality of life questionnaire routinely as part of their care on our LVAD clinic. Additionally, periodic echcoardiography is obtained to determine LVAD dynamics and ventrocular dimensions. We will utilize this information for our study, as well as information from their cardiac resynchronization devices, which is part of routine care for patietns with pacemakers and defibrillators.
Who may be able to join
- Presence of LVAD support and CRT device with working LV lead in patients > 18years of age
- Left ventricular pacing at time of enrollment
Who cannot join
- LV lead dysfunction
- Prior AV node ablation
- Presence of total heart block
- Presence of significant bradycardia/lack of underlying rhythm
- Inability to complete 6 minute walk test
- Inability to return to clinic for repeat assessment
- Any LVAD programmed speed change within the prior 30 days
- Any CRT programming changes within the prior 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effects of Cardiac Resynchronization Therapy (CRT) and Left Ventricular Assist Devices (LVAD) Therapy
Cardiac resynchronization therapy (CRT) or biventricular pacing is a useful treatment for heart failure and those suffering from arrhythmias. The purpose of this research study is to determine the effect left-ventricular pacing has on patients who have a ventricular assist device.
Read the detailed description
As part of the study participation the following two visits will be completed as listed below.
Baseline Visit: The following procedures will be conducted at this visit:
- Review of past medical history and medical records;
- A limited echocardiogram will be performed. This is a test that uses ultrasound to evaluate the size of the heart and how well the heart is pumping blood.
- The investigators will use a computer-like device, called a programmer, that "talks" to the CRT device using radio signals or by using wanded telemetry to adjust the CRT device's programmed settings. The left ventricular lead of your device will be turned off. The defibrillator will continue to function and back-up pacing will continue if needed.
- Complete the Kansas City Cardiomyopathy Questionnaire (KCCQ).
- A 6 minute walk test will be done.
Regularly Scheduled Clinic Visit: At the next regularly scheduled Left Ventricular Assist Devices (LVAD) clinic visit, approximately 4 weeks after the baseline visit, the following procedures will be done:
- A second limited echocardiogram.
- The investigator will use a computer-like device, called a programmer, that "talks" to the CRT device using radio signals or by using a wand to obtain a report that will give the current program settings and any heart rhythm events that have occurred since the last CRT device was checked. Once the information from the CRT is obtained, the study doctor will reprogram the device to its original settings.
- Complete the Kansas City Cardiomyopathy Questionnaire (KCCQ).
- A 6 minute walk test will be done.
- Conditions
- Heart Failure
- Being tested
- LVAD CRT
- Keywords
- Left Ventricular Assist Devices (LVAD), Cardiac Resynchronization Devices (CRT)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVAD CRTDevice
The following procedures will be performed: limited echocardiogram, an adjustment to the CRT device's programmed settings, follow-up in 30 days to adjust the CRT device's programmed settings. In addition, quality of life questionnaires will be filled out and a 6 minute walk test will be completed.
| Study group | Role | What they receive |
|---|---|---|
| LVAD CRT | The following procedures will be performed: limited echocardiogram, an adjustment to the CRT device's programmed settings, follow-up in 30 days to adjust the CRT device's programmed settings. In addition, quality of life questionnaires will be filled out and a 6 minute walk test will be completed. Receives: Device: LVAD CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in echocardiographic parameters
A comparison of the echocardiogram completed at enrollment and at 30 days.
Measured: Change in baseline to 30 days
6 minute walk distance
A trained staff member will supervise participants in the completion of a 6 minute walk test. They will be instructed to walk on a level surface, on a clearly marked indoor course. heart rate and oxygen level will be monitored. The total distance completed at the end of 6 minutes will be noted.
Measured: Change in baseline to 30 days
Quality of Life
A comparison of the questionnaires completed at enrollment and at 30 days.
Measured: Change in baseline to 30 days
Number of Ventricular Tachycardia Episodes
At baseline and again at 30 days CRT device interrogation will be done to count the number of ventricular tachycardia episodes with LV pacing on and off.
Measured: Change in baseline to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study start28 Apr 2014
- Primary completionJan 2017
- Study completion2 Feb 2017
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.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mustafa Ahmed, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083419
- Sponsor's protocol ID
- IRB201300694
- Status last verified
- Feb 2017
- First submitted
- 4 Mar 2014
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Cardiac Resynchronization Therapy (CRT) and Left Ventricular Assist Devices (LVAD) Therapy
- ClinicalTrials.gov ID
- NCT02083419
- Acronym / sponsor ID
- IRB201300694
- Conditions
- Heart Failure
- Keywords
- Left Ventricular Assist Devices (LVAD), Cardiac Resynchronization Devices (CRT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 28 Apr 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 11 Mar 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.
Cardiac resynchronization therapy (CRT) or biventricular pacing is a useful treatment for heart failure and those suffering from arrhythmias. The purpose of this research study is to determine the effect left-ventricular pacing has on patients who have a ventricular assist device.
Detailed description
As part of the study participation the following two visits will be completed as listed below.
Baseline Visit: The following procedures will be conducted at this visit:
- Review of past medical history and medical records;
- A limited echocardiogram will be performed. This is a test that uses ultrasound to evaluate the size of the heart and how well the heart is pumping blood.
- The investigators will use a computer-like device, called a programmer, that "talks" to the CRT device using radio signals or by using wanded telemetry to adjust the CRT device's programmed settings. The left ventricular lead of your device will be turned off. The defibrillator will continue to function and back-up pacing will continue if needed.
- Complete the Kansas City Cardiomyopathy Questionnaire (KCCQ).
- A 6 minute walk test will be done.
Regularly Scheduled Clinic Visit: At the next regularly scheduled Left Ventricular Assist Devices (LVAD) clinic visit, approximately 4 weeks after the baseline visit, the following procedures will be done:
- A second limited echocardiogram.
- The investigator will use a computer-like device, called a programmer, that "talks" to the CRT device using radio signals or by using a wand to obtain a report that will give the current program settings and any heart rhythm events that have occurred since the last CRT device was checked. Once the information from the CRT is obtained, the study doctor will reprogram the device to its original settings.
- Complete the Kansas City Cardiomyopathy Questionnaire (KCCQ).
- A 6 minute walk test will be done.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LVAD CRT | – | Device: LVAD CRTThe following procedures will be performed: limited echocardiogram, an adjustment to the CRT device's programmed settings, follow-up in 30 days to adjust the CRT device's programmed settings. In addition, quality of life questionnaires will be filled out and a 6 minute walk test will be completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with ventricular dysfunction, dyssynchrony, functional capacity presence of arrhythmia. LVAD patients undergo 6 minute walk testing and complete a quality of life questionnaire routinely as part of their care on our LVAD clinic. Additionally, periodic echcoardiography is obtained to determine LVAD dynamics and ventrocular dimensions. We will utilize this information for our study, as well as information from their cardiac resynchronization devices, which is part of routine care for patietns with pacemakers and defibrillators.
Key inclusion criteria (2 listed)
- Presence of LVAD support and CRT device with working LV lead in patients > 18years of age
- Left ventricular pacing at time of enrollment
Key exclusion criteria (8 listed)
- LV lead dysfunction
- Prior AV node ablation
- Presence of total heart block
- Presence of significant bradycardia/lack of underlying rhythm
- Inability to complete 6 minute walk test
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 |
|---|---|---|
| LVAD CRTThe following procedures will be performed: limited echocardiogram, an adjustment to the CRT device's programmed settings, follow-up in 30 days to adjust the CRT device's programmed settings. In addition, quality of life questionnaires will be filled out and a 6 minute walk test will be completed. | Device | LVAD CRT |
Primary outcome
Change in echocardiographic parameters
Time frame: Change in baseline to 30 days
A comparison of the echocardiogram completed at enrollment and at 30 days.
6 minute walk distance
Time frame: Change in baseline to 30 days
A trained staff member will supervise participants in the completion of a 6 minute walk test. They will be instructed to walk on a level surface, on a clearly marked indoor course. heart rate and oxygen level will be monitored. The total distance completed at the end of 6 minutes will be noted.
Quality of Life
Time frame: Change in baseline to 30 days
A comparison of the questionnaires completed at enrollment and at 30 days.
Number of Ventricular Tachycardia Episodes
Time frame: Change in baseline to 30 days
At baseline and again at 30 days CRT device interrogation will be done to count the number of ventricular tachycardia episodes with LV pacing on and off.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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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.
Mustafa Ahmed, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of Florida 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 8 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: finished, as of the sponsor's last update on 8 Feb 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in echocardiographic parameters (time frame: Change in baseline to 30 days). 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 8 Feb 2017.