Left Ventricular Capture Management (LVCM) Software Download Clinical Trial

NCT00268281 | Completed

• 1 other identifier: 238
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 18

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

Conditions

Heart Failure

Keywords

cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Interventions

Left Ventricular Capture Management Software DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who successfully underwent implantation of an InSync II Marquis system

You may not qualify if:

• Subjects who are post-heart transplant
• Subjects enrolled in a concurrent study that may confound the results of this study

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (18)

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Little Rock, Arkansas, United States

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Unknown Facility

Palo Alto, California, United States

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Bridgeport, Connecticut, United States

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Atlantis, Florida, United States

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Ormond Beach, Florida, United States

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Unknown Facility

Oak Lawn, Illinois, United States

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Unknown Facility

Indianapolis, Indiana, United States

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Unknown Facility

Portland, Maine, United States

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Minneapolis, Minnesota, United States

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Kansas City, Missouri, United States

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Unknown Facility

West Orange, New Jersey, United States

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Charlotte, North Carolina, United States

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Wynnewood, Pennsylvania, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Richmond, Virginia, United States

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Unknown Facility

Morgantown, West Virginia, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 21, 2005
• First Posted: December 22, 2005
• Study Start: December 1, 2004
• Study Completion: July 1, 2005
• Last Updated: October 13, 2006

Record last verified: 2006-10

Locations

US (18)