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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

1202

Study ID:

NCT01751022

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There is 1 Location for this study

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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

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Houma Louisiana, , United States

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Boston Massachusetts, , United States

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Kansas Missouri, , United States

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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

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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

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Graz , , Austria

Linz , , Austria

Genk , , Belgium

Yvoir , , Belgium

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Quebec , , Canada

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København , , Denmark

Ã…rhus N , , Denmark

Helsinki , , Finland

Nantes , , France

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Rouen Cedex , , France

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Bernau , , Germany

Bielefeld , , Germany

Chemnitz , , Germany

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Trier , , Germany

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Dehli , , India

Ashkelon , , Israel

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Eindhoven , , Netherlands

Maastricht , , Netherlands

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Bergen , , Norway

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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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

1202

Study ID:

NCT01751022

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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