Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Cardiac Rhythm and Heart Failure
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
* 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
