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Cardiac Resynchronization Therapy (CRT) and Left Ventricular Assist Devices (LVAD) Therapy

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ClinicalTrials.gov Identifier: NCT02083419
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment
Heart Failure Device: LVAD CRT

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.

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of the Effects of Cardiac Resynchronization Therapy (CRT) and Left Ventricular Assist Devices (LVAD) Therapy
Actual Study Start Date : April 28, 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
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.
Device: 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.




Primary Outcome Measures :
  1. Change in echocardiographic parameters [ Time Frame: Change in baseline to 30 days ]
    A comparison of the echocardiogram completed at enrollment and at 30 days.

  2. 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.

  3. Quality of Life [ Time Frame: Change in baseline to 30 days ]
    A comparison of the questionnaires completed at enrollment and at 30 days.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Presence of LVAD support and CRT device with working LV lead in patients > 18years of age
  • Left ventricular pacing at time of enrollment

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083419


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Mustafa Ahmed, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02083419    
Other Study ID Numbers: IRB201300694
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Keywords provided by University of Florida:
Left Ventricular Assist Devices (LVAD)
Cardiac Resynchronization Devices (CRT)
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases