Stimulus Intensity in Left Ventricular Leads (SILVeR-CRT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Congestive Heart Failure |
Other: LV stimulus intensity |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Stimulus Intensity in Left Ventricular Leads and Response to Cardiac Resynchronization Therapy |
- Ejection Fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
LV lead low output
Low output on left ventricular pacing lead.
|
Other: LV stimulus intensity
The voltage and pulse duration used for programmed LV pacing
|
|
LV lead high output
High output on left ventricular lead
|
Other: LV stimulus intensity
The voltage and pulse duration used for programmed LV pacing
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults who are able to give informed consent who otherwise fulfill approved criteria to receive a cardiac resynchronization device.
Contacts and Locations More Information
No publications provided by Emory University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael S. Lloyd MD, Assistant Professor of Medicine, Emory University |
| ClinicalTrials.gov Identifier: | NCT01060449 History of Changes |
| Other Study ID Numbers: | Medtronic-639130, 00016194 |
| Study First Received: | January 29, 2010 |
| Last Updated: | June 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
cardiac resynchronization therapy congestive heart failure |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013