SILVeR-CRT: Stimulus Intensity in Left Ventricular Leads

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT01060449

Collaborator

Medtronic (Industry)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Other: LV stimulus intensity	N/A

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 Design

Study Type:

Interventional

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 :

Aug 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: 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
Other: 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

Arm

Intervention/Treatment

Other: 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

Other: 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

Outcome Measures

Primary Outcome Measures

Ejection Fraction [6 months]

Secondary Outcome Measures

Quality of Life [6 months]
Six minute hall walk [6 months]
End diastolic dimension [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

-Adults who are unable to give informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

Emory University
Medtronic

Investigators

Principal Investigator: Michael S. Lloyd, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael S. Lloyd, Principal Investigator, Emory University

ClinicalTrials.gov Identifier:

NCT01060449

Other Study ID Numbers:

IRB00016194
Medtronic-639130

First Posted:

Feb 2, 2010

Last Update Posted:

Dec 17, 2013

Last Verified:

Dec 1, 2013

Keywords provided by Michael S. Lloyd, Principal Investigator, Emory University

cardiac resynchronization therapy

congestive heart failure

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Dec 17, 2013