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Stimulus Intensity in Left Ventricular Leads (SILVeR-CRT)

Emory University logo

Emory University

Status

Completed

Conditions

Congestive Heart Failure

Treatments

Other: LV stimulus intensity

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01060449
Medtronic-639130 (Other Identifier)
IRB00016194

Details and patient eligibility

About

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).

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

-Adults who are unable to give informed consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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