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Stimulus Intensity in Left Ventricular Leads (SILVeR-CRT)

Primary Purpose

Congestive Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

LV stimulus intensity

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring cardiac resynchronization therapy, congestive heart failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Emory University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

LV lead low output

LV lead high output

Arm Description

Low output on left ventricular pacing lead. Intervention: LV stimulus intensity

High output on left ventricular lead Intervention: LV stimulus intensity

Outcomes

Primary Outcome Measures

Ejection Fraction

Secondary Outcome Measures

Quality of Life

Six minute hall walk

End diastolic dimension

Full Information

NCT ID

NCT01060449

First Posted

January 29, 2010

Last Updated

December 15, 2013

Sponsor

Emory University

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT01060449

Brief Title

Stimulus Intensity in Left Ventricular Leads

Acronym

SILVeR-CRT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congestive Heart Failure

Keywords

cardiac resynchronization therapy, congestive heart failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LV lead low output

Arm Type

Other

Arm Description

Low output on left ventricular pacing lead. Intervention: LV stimulus intensity

Arm Title

LV lead high output

Arm Type

Other

Arm Description

High output on left ventricular lead Intervention: LV stimulus intensity

Intervention Type

Other

Intervention Name(s)

LV stimulus intensity

Intervention Description

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

Primary Outcome Measure Information:

Title

Ejection Fraction

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Quality of Life

Time Frame

6 months

Title

Six minute hall walk

Time Frame

6 months

Title

End diastolic dimension

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults who fulfill approved criteria to receive a cardiac resynchronization device. Exclusion Criteria: -Adults who are unable to give informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael S. Lloyd, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23316285

Citation

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.

Results Reference

result

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Stimulus Intensity in Left Ventricular Leads

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