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Left Ventricular Capture Management (LVCM) Software Download Clinical Trial

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Left Ventricular Capture Management Software
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring cardiac resynchronization therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects who successfully underwent implantation of an InSync II Marquis system Exclusion Criteria: Subjects who are post-heart transplant Subjects enrolled in a concurrent study that may confound the results of this study

Sites / Locations

Outcomes

Primary Outcome Measures

To evaluate the accuracy of left ventricular capture management (LVCM)

Secondary Outcome Measures

To compare left ventricular capture management (LVCM) measurements to a similar measurement taken automatically when subjects are completing normal daily activities
To evaluate subject rhythm and rate immediately following an LVCM measurements
To characterize all adverse events

Full Information

First Posted
December 21, 2005
Last Updated
October 11, 2006
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT00268281
Brief Title
Left Ventricular Capture Management (LVCM) Software Download Clinical Trial
Official Title
Left Ventricular Capture Management (LVCM) Software Download Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

5. Study Description

Brief Summary
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. Left Ventricular Capture Management (LVCM) refers to the overall method for determining left ventricular thresholds (level of energy needed to effectively pace the tissue in the lower left chamber of the heart) by measuring, analyzing, and adjusting energy delivered from the CRT device to the pacing lead. The purpose of the Left Ventricular Capture Management Software Download Clinical Trial was to evaluate the accuracy of the Left Ventricular Capture Management (LVCM) feature to support LVCM feature approval in future cardiac resynchronization therapy with defibrillation (CRT-D) devices

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
cardiac resynchronization therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
107 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Left Ventricular Capture Management Software
Primary Outcome Measure Information:
Title
To evaluate the accuracy of left ventricular capture management (LVCM)
Secondary Outcome Measure Information:
Title
To compare left ventricular capture management (LVCM) measurements to a similar measurement taken automatically when subjects are completing normal daily activities
Title
To evaluate subject rhythm and rate immediately following an LVCM measurements
Title
To characterize all adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who successfully underwent implantation of an InSync II Marquis system Exclusion Criteria: Subjects who are post-heart transplant Subjects enrolled in a concurrent study that may confound the results of this study
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Palo Alto
State/Province
California
Country
United States
City
Bridgeport
State/Province
Connecticut
Country
United States
City
Atlantis
State/Province
Florida
Country
United States
City
Ormond Beach
State/Province
Florida
Country
United States
City
Oak Lawn
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Portland
State/Province
Maine
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
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Kansas City
State/Province
Missouri
Country
United States
City
West Orange
State/Province
New Jersey
Country
United States
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Charlotte
State/Province
North Carolina
Country
United States
City
Wynnewood
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States

12. IPD Sharing Statement

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