Clinical trial NCT00291564: Ensure Cardiac Resynchronization Therapy Study
Official title: Ensure Cardiac Resynchronization Therapy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Observational
Heart Failure
Continuous Cardiac Resynchronization Therapy
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-02-14
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to gather information on how doctors program particular settings on cardiac resynchronization therapy implantable cardiac defibrillators (CRT-Ds), to analyze how these settings affect the amount of cardiac resynchronization therapy (CRT) patients receive and to evaluate the therapy approach for converting abnormally fast heartbeats into normal heartbeats. There are no experimental devices or procedures involved in this study.


Eligibility criteria: Inclusion Criteria:

* Patient is indicated for a Medtronic CRT-D system
* Patient is willing to sign Permission for Access to and Use of Health Information form
* Patient is willing and able to comply with follow-up visits through six months

Exclusion Criteria:

* Patient has a life expectancy of less than 6 months
* Patient is participating in any concurrent study that could confound the results for either study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Newport Beach
country: United States
state: California
city: Trumbull
country: United States
state: Connecticut
city: Daytona Beach
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Kankakee
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Owensboro
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Salisbury
country: United States
state: Maryland
city: Burlington
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Mexico
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Bridgewater
country: United States
state: New Jersey
city: Englewood
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Abington
country: United States
state: Pennsylvania
city: Doylestown
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Tennessee Cardiovascular Research Institute
name: David Thompson, MD
role: PRINCIPAL_INVESTIGATOR
References: