Attain Performa(TM) Quadripolar Lead Study
Attain Performa(TM) Quadripolar Lead Study
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.
Inclusion Criteria:
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.)
Patient is unable to tolerate an urgent thoracotomy
Standford, California, United States
Burlington, Virginia, United States
Århus N, Denmark
Ljublijana, Slovenia