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Stimulus Intensity in Left Ventricular Leads

NCT ID: NCT01060449

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Congestive Heart Failure

Keywords

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cardiac resynchronization therapy congestive heart failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LV lead low output

Low output on left ventricular pacing lead.

Intervention: LV stimulus intensity

Group Type OTHER

LV stimulus intensity

Intervention Type OTHER

The voltage and pulse duration used for programmed LV pacing

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

LV lead high output

High output on left ventricular lead

Intervention: LV stimulus intensity

Group Type OTHER

LV stimulus intensity

Intervention Type OTHER

The voltage and pulse duration used for programmed LV pacing

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

Interventions

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LV stimulus intensity

The voltage and pulse duration used for programmed LV pacing

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-Adults who are unable to give informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Michael S. Lloyd

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael S. Lloyd, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Bavikati VV, Langberg JJ, Williams BR 3rd, Kella D, Lloyd MS. Stimulus intensity in left ventricular leads and response to cardiac resynchronization therapy. J Am Heart Assoc. 2012 Oct;1(5):e000950. doi: 10.1161/JAHA.112.000950. Epub 2012 Oct 25.

Reference Type RESULT
PMID: 23316285 (View on PubMed)

Other Identifiers

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Medtronic-639130

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00016194

Identifier Type: -

Identifier Source: org_study_id