Clinical trial NCT00856349: Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
Official title: Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: Implantable Cardioverter Defibrillator (ICD)
Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
Lead Integrity Alert (LIA)
Therapy Programming Report (TPR)
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 4384
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects implanted with a Medtronic market released single, dual, or triple chamber defibrillator (US/Canada - Concerto®/Virtuoso® or newer model; AsiaPacific, Israel, Latin America - EnTrust™, InSync Sentry®, or Concerto®/Virtuoso® or newer model) within the past 30 days are eligible for participation in the study.

Brief summary: The purpose of this clinical trial is to determine whether periodic therapy programming reports illustrating physician usage of shock reduction programming can increase utilization of recommended programming guidelines for defibrillators.

Detailed description: Shocks delivered to patients by defibrillators, while life-saving, can create anxiety, pain and decrease quality of life. Previous studies have shown that device programming and features can safely reduce the number of shocks patients receive. This study will explore the extent to which physicians use these programming and features. It will determine whether repeat and frequent awareness to how they program their own subjects and the programming trends of all enrolled subjects will change their programming patterns. This will be accomplished by understanding physicians' device programming behaviors and providing reports as a tool to help physicians manage their subjects and provide shock reduction programming recommended by previous publications.

Eligibility criteria: Inclusion Criteria:

* Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Consent Form (PCF) and authorization for access to and use of health information, if applicable
* Subject has been implanted with a Medtronic market released ICD or CRT-D device (US/Canada - Concerto®/Virtuoso® or newer model; AsiaPacific, Israel, Latin America - EnTrust™, InSync Sentry®, or Concerto®/Virtuoso® or newer model) within the past 30 days
* Subject has commercially released RA (if applicable), RV, and LV (if applicable) leads

Exclusion Criteria:

* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader

Primary outcomes:
measure: Change in Shock Reduction Programming Adoption
timeFrame: Overall study (20 months on average)
Secondary outcomes:
measure: Lead Integrity Alert (LIA) Performance
timeFrame: Overall study (20 months on average)
measure: Reasons for Inappropriate Shocks
timeFrame: Overall study (20 months on average)
measure: Actions Taken Following a Shock
timeFrame: Overall study (20 months on average)
measure: Barriers to Utilization of Shock Reduction Programming
timeFrame: 24 months follow-up visit
measure: Relationship of Subject Characteristics and Geographical Regions With Shock Reduction Programming Utilization
timeFrame: Overall study (20 months on average)
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Fremont
country: United States
state: California
city: Fresno
country: United States
state: California
city: Modesto
country: United States
state: California
city: Northridge
country: United States
state: California
city: Orange
country: United States
state: California
city: San Bernardino/Los Angeles
country: United States
state: California
city: Ventura
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Fort Lauderdale
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Rockledge
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Berwyn
country: United States
state: Illinois
city: Elk Grove Village
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Fort Wayne
country: United States
state: Indiana
city: Scarborough
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: New Bedford
country: United States
state: Massachusetts
city: Flint
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: St. Joseph
country: United States
state: Michigan
city: Robbinsdale
country: United States
state: Minnesota
city: St. Louis Park
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: St. Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Cherry Hill
country: United States
state: New Jersey
city: Clifton
country: United States
state: New Jersey
city: Flemington
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Elmira
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: New York
country: United States
state: New York
city: Utica
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Mansfield
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Lawton
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Erie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Chattanooga
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: El Paso
country: United States
state: Texas
city: Fort Sam Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Mc Allen
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Manassas
country: United States
state: Virginia
city: Charleston
country: United States
state: West Virginia
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Adelaide
country: Australia
state: South Australia
city: Frankston
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Edmonton
country: Canada
state: Alberta
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Kitchener
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montréal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Guangzhou
country: China
state: Guangdong
city: Beijing
country: China
city: Kowloon
country: Hong Kong
city: New Dehli
country: India
state: Delhi
city: Saket
country: India
state: New Dehli
city: Seoul
country: Korea, Republic of
city: Mexico City
country: Mexico
city: Frankton
country: New Zealand
state: Hamilton
city: Singapore
country: Singapore
city: Kaohsiung
country: Taiwan
Study officials:
affiliation: Raleigh Cardiology Associates
name: Marc Silver, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joung B, Lexcen DR, Ching CK, Silver MT, Piccini JP, Sterns LD, Rabinovich R, Pickett RA, Liu S, Brown ML, Cheng A. Additional antitachycardia pacing programming strategies further reduce unnecessary implantable cardioverter-defibrillator shocks. Heart Rhythm. 2020 Jan;17(1):98-105. doi: 10.1016/j.hrthm.2019.07.027. Epub 2019 Jul 29.