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Left Ventricular Capture Management (LVCM) Software Download Clinical Trial

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00268281
First received: December 21, 2005
Last updated: October 11, 2006
Last verified: October 2006
History of Changes
  Purpose

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


Condition Intervention
Heart Failure
 Device: Left Ventricular Capture Management Software

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Left Ventricular Capture Management (LVCM) Software Download Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

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

Estimated Enrollment: 107
Study Start Date: December 2004
Estimated Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268281

  Show 18 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00268281     History of Changes
Other Study ID Numbers: 238
Study First Received: December 21, 2005
Last Updated: October 11, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
cardiac resynchronization therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013