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Recruiting
I'm InterestedTrial ID: NCT01751022
Attain Performa(TM) Quadripolar Lead Study
Associate Professor of Medicine (Cardiovascular Medicine)
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
device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
Recruiting
I'm Interested
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Linda Norton, RN, MSN
(650) 725-5597