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

NCT ID: NCT02083419

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-28
• Study Completion Date: 2017-02-02

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

LVAD CRT

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mustafa Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201300694

Identifier Type: -

Identifier Source: org_study_id