Clinical trial NCT00268281: Left Ventricular Capture Management (LVCM) Software Download Clinical Trial
Official title: Left Ventricular Capture Management (LVCM) Software Download Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: cardiac resynchronization therapy
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2005-12-22
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: To evaluate the accuracy of left ventricular capture management (LVCM)
Secondary outcomes:
measure: To compare left ventricular capture management (LVCM) measurements to a similar measurement taken automatically when subjects are completing normal daily activities
measure: To evaluate subject rhythm and rate immediately following an LVCM measurements
measure: To characterize all adverse events
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Palo Alto
country: United States
state: California
city: Bridgeport
country: United States
state: Connecticut
city: Atlantis
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Oak Lawn
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Portland
country: United States
state: Maine
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: West Orange
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Wynnewood
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
Study officials:
References: