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Stimulus Intensity in Left Ventricular Leads

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01060449
Acronym
SILVeR-CRT
Enrollment
60
Registered
2010-02-02
Start date
2008-08-31
Completion date
2012-02-29
Last updated
2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

cardiac resynchronization therapy, congestive heart failure

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.

Interventions

OTHERLV stimulus intensity

The voltage and pulse duration used for programmed LV pacing Arm 1: LV lead low output Arm 2: LV lead high output

Sponsors

Medtronic
CollaboratorINDUSTRY
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Ejection Fraction6 months

Secondary

MeasureTime frame
End diastolic dimension6 months
Quality of Life6 months
Six minute hall walk6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026