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Stimulus Intensity in Left Ventricular Leads (SILVeR-CRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01060449
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : December 17, 2013
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Michael S. Lloyd, Emory University

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).

Condition or disease Intervention/treatment
Congestive Heart Failure Other: LV stimulus intensity

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stimulus Intensity in Left Ventricular Leads and Response to Cardiac Resynchronization Therapy
Study Start Date : August 2008
Primary Completion Date : June 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
LV lead low output

Low output on left ventricular pacing lead.

Intervention: LV stimulus intensity

Other: 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

LV lead high output

High output on left ventricular lead

Intervention: LV stimulus intensity

Other: 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




Primary Outcome Measures :
  1. Ejection Fraction [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 6 months ]
  2. Six minute hall walk [ Time Frame: 6 months ]
  3. End diastolic dimension [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-Adults who are unable to give informed consent.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060449


Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Medtronic
Investigators
Principal Investigator: Michael S. Lloyd, MD Emory University

Publications:
Responsible Party: Michael S. Lloyd, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01060449     History of Changes
Other Study ID Numbers: IRB00016194
Medtronic-639130 ( Other Identifier: Sponsor )
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Michael S. Lloyd, Emory University:
cardiac resynchronization therapy
congestive heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases