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OpenTrials
Completed

NCT Number: NCT01060449

Stimulus Intensity in Left Ventricular Leads

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).

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-Adults who are unable to give informed consent.

Treatment and study plan

LV stimulus intensity

Other

The voltage and pulse duration used for programmed LV pacing

Arm 1: LV lead low output Arm 2: LV lead high output

Primary outcomes

  1. Ejection Fraction

    Time frame: 6 months

Secondary outcomes

  1. Quality of Life

    Time frame: 6 months

  2. Six minute hall walk

    Time frame: 6 months

  3. End diastolic dimension

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Medtronic

Registry information

Official study title

Stimulus Intensity in Left Ventricular Leads and Response to Cardiac Resynchronization Therapy

Acronym: SILVeR-CRT

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Feb 2, 2010
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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