Clinical trial NCT00990964: Attain Success Clinical Trial
Official title: Attain Success Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 2014
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient referral to a participating study center with practitioners experienced in handling and implantation of the cardiac resynchronization therapy (CRT) device, the left-heart lead, and the use of the delivery catheter.

Brief summary: The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age or older
* Subject will be implanted with Medtronic cardiac resynchronization therapy (CRT) device and Medtronic left heart lead utilizing (or attempting to utilize) Attain Family of delivery catheters. The implant procedure may include upgrades to CRT from implantable pulse generator (IPG) or implantable cardioverter-defibrillator (ICD).

Exclusion Criteria:

* Subject is enrolled in a concurrent study with the exception of a study approved by the Medtronic Clinical Trial Leader prior to enrollment
* Subject has existing CRT system implanted or was previously implanted with a CRT system.

Primary outcomes:
measure: Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter
timeFrame: Implant
measure: Subjects Without a Left-heart Lead and Delivery Catheter Related Complication
timeFrame: Implant to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Downey
country: United States
state: California
city: Modesto
country: United States
state: California
city: Redding
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Jose
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Danbury
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Delray Beach
country: United States
state: Florida
city: Lake Mary
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: St. Augustine
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Athens
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Decatur
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Bowling Green
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Houma
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Muskegon
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Saint Clair Shore
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Washinton
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Concord
country: United States
state: New Hampshire
city: Englewood
country: United States
state: New Jersey
city: Huntington
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Concord
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Kettering
country: United States
state: Ohio
city: Abington
country: United States
state: Pennsylvania
city: Bethlehem
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Harrisburg
country: United States
state: Pennsylvania
city: Wormleysburg
country: United States
state: Pennsylvania
city: Florence
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Knoxsville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Brownsville
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Frederickburg
country: United States
state: Virginia
city: Bellingham
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Green Bay
country: United States
state: Wisconsin
city: Ontario
country: Canada
city: Jiangsu
country: China
city: Sichuan
country: China
city: Xinjian
country: China
city: Amiens
country: France
city: Anglouleme
country: France
city: Bayonne
country: France
city: Bordeaux
country: France
city: Clermont-Ferrand
country: France
city: Creteil
country: France
city: Metz-Tessy
country: France
city: Montfermeil
country: France
city: Nice
country: France
city: Orleans
country: France
city: Paris
country: France
city: Poitiers
country: France
city: Villingen
country: Germany
city: Sha Tin
country: Hong Kong
city: Haryana
country: India
city: New Dehli
country: India
city: New Delhi
country: India
city: Rajasthan
country: India
city: Vizag
country: India
city: Kuala Lumpur
country: Malaysia
city: Tal-Qroqq
country: Malta
city: Lahore
country: Pakistan
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Zabreze
country: Poland
city: San Juan
country: Puerto Rico
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Novena
country: Singapore
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
Study officials:
affiliation: Davis Heart & Lung Research Institute, The Ohio State University
name: John D Hummel, MD
role: PRINCIPAL_INVESTIGATOR
References: