Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
1202 participants
INTERVENTIONAL
2012-12-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Attain Performa LV Lead (Models 4298, 4398, 4598)
N/A: single arm study, separate analysis for each lead model (total of 3).
Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Implant and follow-up of study lead, separate analysis for each lead model
Interventions
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Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Implant and follow-up of study lead, separate analysis for each lead model
Eligibility Criteria
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Inclusion Criteria
* Patient (or legally authorized representative) has signed and dated the study-specific Consent Form
* Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
* Patient is expected to remain available for follow-up visits
* Patient understands the study and agrees to comply with study protocol
Exclusion Criteria
* Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
* Patient has had a heart transplant (Note: Patients waiting for heart transplants are allowed in the study)
* Patient is contraindicated for \< 1 mg dexamethasone acetate
* Patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (Note: Co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from Medtronic's study manager)
* Patient has a life expectancy less than 180 days
* In US, women of childbearing potential must have a negative pregnancy test 7 days prior to implant to be included
* Patient is unable to tolerate an urgent thoracotomy
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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Glendale, California, United States
Riverside, California, United States
San Diego, California, United States
San Jose, California, United States
Standford, California, United States
West Hollywood, California, United States
Hartford, Connecticut, United States
Atlantis, Florida, United States
Boca Raton, Florida, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
West Des Moines, Iowa, United States
Kansas City, Kansas, United States
Edgewood, Kentucky, United States
Houma, Louisiana, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Lansing, Michigan, United States
Royal Oak, Michigan, United States
Minneapolis, Minnesota, United States
Saint Cloud, Minnesota, United States
Saint Louis Park, Minnesota, United States
Tupelo, Mississippi, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Henderson, Nevada, United States
Morristown, New Jersey, United States
Ridgewood, New Jersey, United States
New York, New York, United States
Stony Brook, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Erie, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Wilkes-Barre, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Greenville, South Carolina, United States
Spartanburg, South Carolina, United States
Germantown, Tennessee, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Temple, Texas, United States
Burlington, Virginia, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Randwick, New South Wales, Australia
Chermside, Queensland, Australia
Adelaide, South Australia, Australia
Heidelberg, Victoria, Australia
Perth, Western Australia, Australia
Graz, , Austria
Linz, , Austria
Genk, , Belgium
Yvoir, , Belgium
Calgary, , Canada
London, , Canada
Montreal, , Canada
Newmarket, , Canada
Québec, , Canada
Santiago, , Chile
Århus N, , Denmark
Copenhagen, , Denmark
Helsinki, , Finland
Nantes, , France
Rennes, , France
Rouen, , France
Bad Rothenfelde, , Germany
Bernau, , Germany
Bielefeld, , Germany
Chemnitz, , Germany
Heidelberg, , Germany
Trier, , Germany
Athens, , Greece
Budapest, , Hungary
Gurgaon, Haryana, India
Dehli, , India
Ashkelon, , Israel
Bologna, , Italy
Cefalù, , Italy
Rovigo, , Italy
Kuala Lumpur, , Malaysia
Eindhoven, , Netherlands
Maastricht, , Netherlands
Nieuwegein, , Netherlands
Bergen, , Norway
Bucharest, , Romania
Riyadh, , Saudi Arabia
Belgrade, , Serbia
Kamenitz, , Serbia
Niš, , Serbia
Bratislava, , Slovakia
Košice, , Slovakia
Ljublijana, , Slovenia
Cape Town, , South Africa
Madrid, , Spain
Lausanne, , Switzerland
Bournemouth, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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Other Identifiers
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Attain Performa(TM)
Identifier Type: -
Identifier Source: org_study_id