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
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring cardiac resynchronization therapy, congestive heart failure
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.
Sites / Locations
- Emory University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
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
No
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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