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

NCT02083419 | Completed

• 1 other identifier: IRB201300694
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Left Ventricular Assist Devices (LVAD); Cardiac Resynchronization Devices (CRT)

Outcome Measures

Primary Outcomes (4)

• Change in echocardiographic parameters

  A comparison of the echocardiogram completed at enrollment and at 30 days.

  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.

  Change in baseline to 30 days

• Quality of Life

  A comparison of the questionnaires completed at enrollment and at 30 days.

  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.

  Change in baseline to 30 days

Study Arms (1)

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

Interventions

LVAD CRT DEVICE

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.

LVAD CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mustafa Ahmed, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 11, 2014
• Study Start: April 28, 2014
• Primary Completion: January 1, 2017
• Study Completion: February 2, 2017
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

US (1)