Heart Failure Clinical Trial
Attain Performa(TM) Quadripolar Lead Study
Summary
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.
Eligibility Criteria
Inclusion Criteria:
Patient is indicated for implant of a CRT-D device and left-heart lead per local indications (In US only this is based on Class I and II indications for CRT-D implant per HRS/ACC/AHA guidelines)
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 a previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt
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
Patient with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)
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
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There is 1 Location for this study
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 Missouri, , United States
Saint 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
Quebec , , Canada
Santiago , , Chile
København , , Denmark
Ã…rhus N , , Denmark
Helsinki , , Finland
Nantes , , France
Rennes Cedex 9 , , France
Rouen Cedex , , 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
Bucuresti , , Romania
Riyadh , , Saudi Arabia
Beograd , , Serbia
Niš , , Serbia
Sremska Kamenica , , Serbia
Bratislava 37 , , Slovakia
Kosice , , Slovakia
Ljublijana , , Slovenia
Cape Town , , South Africa
Madrid , , Spain
Lausanne , , Switzerland
Bournemouth , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
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