Trial Search Results

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

Stanford Investigator(s):

Intervention(s):

  • Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)

Phase:

N/A

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linda Norton, RN, MSN
(650) 725-5597
Recruiting