Left Ventricular Capture Management (LVCM) Software Download Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 107
- Primary Endpoint
- To evaluate the accuracy of left ventricular capture management (LVCM)
- Status
- Completed
- Last Updated
- 19 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
To evaluate the accuracy of left ventricular capture management (LVCM)
Secondary Outcomes
- 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