Stimulus Intensity in Left Ventricular Leads

Congestive Heart Failure Clinical Trial

— SILVeR-CRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060449
• Other study ID #: IRB00016194
• Secondary ID: Medtronic-639130
• Status: Completed
• Phase: N/A
• First received: January 29, 2010
• Last updated: December 15, 2013
• Start date: August 2008
• Est. completion date: February 2012

Study information

• Verified date: December 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-Adults who are unable to give informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection Fraction		6 months	No
Secondary	Quality of Life		6 months	No
Secondary	Six minute hall walk		6 months	No
Secondary	End diastolic dimension		6 months	No