Stimulus Intensity in Left Ventricular Leads (SILVeR-CRT)

December 15, 2013 updated by: Michael S. Lloyd, Emory University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Adults who are unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ejection Fraction
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: 6 months
6 months
Six minute hall walk
Time Frame: 6 months
6 months
End diastolic dimension
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Medtronic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 15, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00016194
  • Medtronic-639130 (Other Identifier: Sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congestive Heart Failure

Clinical Trials on LV stimulus intensity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe