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

Tracking Information
First Received Date ^ICMJE	December 21, 2005
Last Updated Date	October 11, 2006
Start Date ^ICMJE	December 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: December 21, 2005)	To evaluate the accuracy of left ventricular capture management (LVCM)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00268281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 21, 2005)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Left Ventricular Capture Management (LVCM) Software Download Clinical Trial
Official Title ^ICMJE	Left Ventricular Capture Management (LVCM) Software Download Clinical Trial
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Heart Failure
Intervention ^ICMJE	Device: Left Ventricular Capture Management Software
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	107
Completion Date	July 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00268281
Other Study ID Numbers ^ICMJE	238
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Medtronic Cardiac Rhythm Disease Management
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medtronic Cardiac Rhythm Disease Management
Verification Date	October 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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