Left Ventricular Capture Management (LVCM) Software Download Clinical Trial

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT00268281

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

107

Starts

2004-12-01

Expected to finish

2005-07-01

Last updated by the study team

2006-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Palo Alto, California, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Atlantis, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Oak Lawn, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Portland, Maine, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — West Orange, New Jersey, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Wynnewood, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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