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CompletedNCT00268281Updated Oct 13, 2006

Left Ventricular Capture Management (LVCM) Software Download Clinical Trial

An interventional study of Left Ventricular Capture Management Software in Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-10-13.

Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
107
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Heart Failure

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Keywords

  • cardiac resynchronization therapy
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 107 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Subjects who are post-heart transplant
  • Subjects enrolled in a concurrent study that may confound the results of this study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
107 participants

Interventions

  • DeviceLeft Ventricular Capture Management Software
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. To compare left ventricular capture management (LVCM) measurements to a similar measurement taken automatically when subjects are completing normal daily activities

  2. To evaluate subject rhythm and rate immediately following an LVCM measurements

  3. To characterize all adverse events

07

Study locations

18 sites
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Palo Alto, California, United States
  • Bridgeport, Connecticut, United States
  • Atlantis, Florida, United States
  • Ormond Beach, Florida, United States
  • Oak Lawn, Illinois, United States
  • Indianapolis, Indiana, United States
  • Portland, Maine, United States
  • Minneapolis, Minnesota, United States
  • Kansas City, Missouri, United States
  • West Orange, New Jersey, United States
  • Charlotte, North Carolina, United States
  • Wynnewood, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Richmond, Virginia, United States
  • Morgantown, West Virginia, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00268281
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
First posted
Dec 22, 2005
Start date
Dec 2004
Completion
Jul 2005
Last update
Oct 13, 2006
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2006. You cannot join it, but the record below documents what was studied.

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