Stimulus Intensity in Left Ventricular Leads (SILVeR-CRT)

This study has been completed.

Sponsor:

Collaborator:

Medtronic

Information provided by:

Emory University

ClinicalTrials.gov Identifier:

NCT01060449

First received: January 29, 2010

Last updated: June 23, 2011

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	January 29, 2010
Last Updated Date	June 23, 2011
Start Date ^ICMJE	August 2009
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 1, 2010)	Ejection Fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01060449 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 1, 2010)	Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ] Six minute hall walk [ Time Frame: 6 months ] [ Designated as safety issue: No ] End diastolic dimension [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Stimulus Intensity in Left Ventricular Leads
Official Title ^ICMJE	Stimulus Intensity in Left Ventricular Leads and Response to Cardiac Resynchronization Therapy
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). The purpose of 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Congestive Heart Failure
Intervention ^ICMJE	Other: LV stimulus intensity The voltage and pulse duration used for programmed LV pacing
Study Arm (s)	LV lead low output Low output on left ventricular pacing lead. Intervention: Other: LV stimulus intensity LV lead high output High output on left ventricular lead Intervention: Other: LV stimulus intensity
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	60
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adults who are able to give informed consent who otherwise fulfill approved criteria to receive a cardiac resynchronization device.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01060449
Other Study ID Numbers ^ICMJE	Medtronic-639130, 00016194
Has Data Monitoring Committee	Yes
Responsible Party	Michael S. Lloyd MD, Assistant Professor of Medicine, Emory University
Study Sponsor ^ICMJE	Emory University
Collaborators ^ICMJE	Medtronic
Investigators ^ICMJE	Not Provided
Information Provided By	Emory University
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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