Left Ventricular Capture Management (LVCM) Software Download Clinical Trial - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	December 21, 2005
Last Updated Date	October 11, 2006
Start Date ^†	December 2004
Current Primary Outcome Measures ^† (submitted: December 21, 2005)	To evaluate the accuracy of left ventricular capture management (LVCM)
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00268281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (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 ^†	Same as current

Descriptive Information
Brief Title ^†	Left Ventricular Capture Management (LVCM) Software Download Clinical Trial
Official Title ^†	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
Study Phase
Study Type ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^†	Heart Failure
Intervention ^†	Device: Left Ventricular Capture Management Software
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	107
Completion Date	July 2005
Primary Completion Date
Eligibility 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00268281
Responsible Party
Secondary IDs ^††
Study Sponsor ^†	Medtronic Cardiac Rhythm Disease Management
Collaborators ^††
Investigators ^†
Information Provided By	Medtronic Cardiac Rhythm Disease Management
Verification Date	October 2006
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.