Stimulus Intensity in Left Ventricular Leads

Not Applicable

Completed

• Conditions: Congestive Heart Failure
• Interventions: Other: LV stimulus intensity

• Registration Number: NCT01060449
• Lead Sponsor: Emory University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2010-01-29
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Primary Completion: 2011-06
• Study Completion: 2012-02
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-15
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adults who fulfill approved criteria to receive a cardiac resynchronization device.

Read More

Exclusion Criteria

-Adults who are unable to give informed consent.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LV lead low output	LV stimulus intensity	Low output on left ventricular pacing lead. Intervention: LV stimulus intensity
LV lead high output	LV stimulus intensity	High output on left ventricular lead Intervention: LV stimulus intensity

Primary Outcome Measures

Name	Time	Method
Ejection Fraction	6 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life	6 months
Six minute hall walk	6 months
End diastolic dimension	6 months

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States