Stimulus Intensity in Left Ventricular Leads and Response to Cardiac Resynchronization Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Ejection Fraction
Study Overview
Brief Summary
Cardiac resynchronization therapy (CRT) is a device implanted to improve the function of some people's hearts. CRT involves the placement of 3 wires in the heart through a vein near the front of your left or right shoulder into three pumping chambers of the heart, the most important being the left lower chamber, left ventricle (LV).
Detailed Description
The purpose of Cardiac resynchronization therapy (CRT) is to send small amounts of energy (called pacing) through the wires to both the left and right lower chambers of your heart at (or near) the same time. This helps the heart pump in a more coordinated way and send more blood to your body with each beat. How much energy is used for pacing is called the stimulus intensity. Increasing the pacing stimulus intensity of the left ventricular wire can lead to an increase in the volume of heart muscle directly stimulated. This has previously been shown to produce beneficial effects on the heart function, like strength of contraction and increased volume of blood pumped. The purpose of this study is to determine if pacing the wires in the left ventricular chamber of the heart using higher stimulus intensity improves the strength of the heart's contraction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults who fulfill approved criteria to receive a cardiac resynchronization device.
Exclusion Criteria
- •Adults who are unable to give informed consent.
Arms & Interventions
LV lead low output
Low output on left ventricular pacing lead.
Intervention: LV stimulus intensity
Intervention: LV stimulus intensity (Other)
LV lead high output
High output on left ventricular lead
Intervention: LV stimulus intensity
Intervention: LV stimulus intensity (Other)
Outcomes
Primary Outcomes
Ejection Fraction
Time Frame: 6 months
Secondary Outcomes
- Quality of Life(6 months)
- Six minute hall walk(6 months)
- End diastolic dimension(6 months)
Investigators
Michael S. Lloyd
Principal Investigator
Emory University