Attain Performa(TM) Quadripolar Lead Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2012
End Date:February 2015

Use our guide to learn which trials are right for you!

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:

- 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
We found this trial at
68
sites
Greenville, South Carolina 29605
2019
mi
from 91732
Greenville, SC
Click here to add this to my saved trials
1932
mi
from 91732
Ann Arbor, MI
Click here to add this to my saved trials
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
2305
mi
from 91732
Atlantis, FL
Click here to add this to my saved trials
1213
mi
from 91732
Austin, TX
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
2312
mi
from 91732
Boca Raton, FL
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
2202
mi
from 91732
Burlington, VA
Click here to add this to my saved trials
Charlotte, North Carolina 28207
2102
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
2032
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
2202
mi
from 91732
Durham, NC
Click here to add this to my saved trials
1875
mi
from 91732
Edgewood, KY
Click here to add this to my saved trials
2116
mi
from 91732
Erie, PA
Click here to add this to my saved trials
2269
mi
from 91732
Fairfax, VA
Click here to add this to my saved trials
1400
mi
from 91732
Fargo, ND
Click here to add this to my saved trials
2315
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
1600
mi
from 91732
Germantown, TN
Click here to add this to my saved trials
13
mi
from 91732
Glendale, CA
Click here to add this to my saved trials
2497
mi
from 91732
Hartford, CT
Click here to add this to my saved trials
218
mi
from 91732
Henderson, NV
Click here to add this to my saved trials
1626
mi
from 91732
Houma, LA
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
1341
mi
from 91732
Kansas, MO
Click here to add this to my saved trials
1339
mi
from 91732
Kansas City, KS
Click here to add this to my saved trials
1994
mi
from 91732
Kingsport, TN
Click here to add this to my saved trials
2313
mi
from 91732
Lancaster, PA
Click here to add this to my saved trials
1894
mi
from 91732
Lansing, MI
Click here to add this to my saved trials
1254
mi
from 91732
Lincoln, NE
Click here to add this to my saved trials
1718
mi
from 91732
Maywood, IL
Click here to add this to my saved trials
627
mi
from 91732
Medford, OR
Click here to add this to my saved trials
1722
mi
from 91732
Milwaukee, WI
Click here to add this to my saved trials
1511
mi
from 91732
Minneapolis, MN
Click here to add this to my saved trials
2122
mi
from 91732
Morgantown, WV
Click here to add this to my saved trials
2407
mi
from 91732
Morristown, NJ
Click here to add this to my saved trials
1763
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
2336
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
2182
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
1227
mi
from 91732
Plano, TX
Click here to add this to my saved trials
7513
mi
from 91732
Randwick,
Click here to add this to my saved trials
2426
mi
from 91732
Ridgewood, NJ
Click here to add this to my saved trials
31
mi
from 91732
Riverside, CA
Click here to add this to my saved trials
2275
mi
from 91732
Rockville, MD
Click here to add this to my saved trials
1962
mi
from 91732
Royal Oak, MI
Click here to add this to my saved trials
1485
mi
from 91732
Saint Cloud, MN
Click here to add this to my saved trials
1573
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
1505
mi
from 91732
Saint Louis Park, MN
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
314
mi
from 91732
San Jose, CA
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
2042
mi
from 91732
Spartanburg, SC
Click here to add this to my saved trials
202
mi
from 91732
Standford, CA
Click here to add this to my saved trials
2503
mi
from 91732
Stony Brook, NY
Click here to add this to my saved trials
2136
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
1218
mi
from 91732
Temple, TX
Click here to add this to my saved trials
1253
mi
from 91732
Tulsa, OK
Click here to add this to my saved trials
1666
mi
from 91732
Tupelo, MS
Click here to add this to my saved trials
1415
mi
from 91732
West Des Moines, IA
Click here to add this to my saved trials
19
mi
from 91732
West Hollywood, CA
Click here to add this to my saved trials
Wilkes-Barre, Pennsylvania 18711
2333
mi
from 91732
Wilkes-Barre, PA
Click here to add this to my saved trials
Winston Salem, North Carolina 27157
2129
mi
from 91732
Winston Salem, NC
Click here to add this to my saved trials
2369
mi
from 91732
Wynnewood, PA
Click here to add this to my saved trials