Attain Performa(TM) Quadripolar Lead Study

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01751022

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

1202

Starts

2012-12-01

Expected to finish

2015-02-01

Last updated by the study team

2016-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — San Jose, California, United States
• Study site — Standford, California, United States
• Study site — West Hollywood, California, United States
• Study site — Hartford, Connecticut, United States
• Study site — Atlantis, Florida, United States
• Study site — Boca Raton, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — West Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Edgewood, Kentucky, United States
• Study site — Houma, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Rockville, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Lansing, Michigan, United States
• Study site — Glendale, California, United States

Full record on ClinicalTrials.gov

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