Left Ventricular Capture Management (LVCM) Software Download Clinical Trial

NCT ID: NCT00268281

Last Updated: 2006-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Heart Failure

Keywords

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cardiac resynchronization therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Left Ventricular Capture Management Software

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Locations

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Phoenix, Arizona, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Palo Alto, California, United States

Site Status

Bridgeport, Connecticut, United States

Site Status

Atlantis, Florida, United States

Site Status

Ormond Beach, Florida, United States

Site Status

Oak Lawn, Illinois, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Portland, Maine, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

Kansas City, Missouri, United States

Site Status

West Orange, New Jersey, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Wynnewood, Pennsylvania, United States

Site Status

Nashville, Tennessee, United States

Site Status

Dallas, Texas, United States

Site Status

Richmond, Virginia, United States

Site Status

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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238

Identifier Type: -

Identifier Source: org_study_id