Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:January 2015
End Date:May 2023
Contact:Silke Krüger, Dr.
Email:QP_ExCELs@biotronik.com
Phone:004930689051335

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

The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP
left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in
the US. The Sentus OTW QP leads received FDA approval on May 4, 2017.

Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed
during the ongoing post approval phase (US sites only).


Inclusion Criteria:

- Standard CRT-D indication according to clinical routine

- De novo implantation or upgrade from existing ICD or pacemaker implant utilizing a
BIOTRONIK CRT-D system with IS4 LV port and Sentus QP LV lead

- Patient is able to understand the nature of the clinical investigation and provide
written informed consent

- Patient is able and willing to complete all routine study visits at the
investigational site through 5 years of follow-up

- Patient accepts Home Monitoring® concept

- Age ≥ 18 years

Exclusion Criteria:

- Contraindication to CRT-D therapy

- Currently implanted with an endocardial or epicardial left ventricular lead or had
prior attempt to place a left ventricular lead

- Cardiac surgical procedure, such as coronary artery bypass graft or valve surgery that
is planned to occur within 6 months after implant or ablation that is planned to occur
within 90 days after implant (ablations planned to occur prior to or at implant are
not exclusionary)

- Expected to receive a heart transplant or ventricular assist device within 6 months

- Life expectancy less than 12 months

- Participation in any other investigational cardiac clinical investigation during the
course of the study

- Presence of another life-threatening, underlying illness separate from their cardiac
disorder

- Pregnant or breast-feeding at time of enrollment
We found this trial at
72
sites
198
mi
from
Kansas City, MO
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283
mi
from
Amarillo, TX
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2734
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from
Anchorage, AK
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874
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from
Anderson, SC
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808
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from
Ann Arbor, MI
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858
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from
Asheville, NC
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801
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from
Atlanta, GA
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402
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from
Aurora, CO
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1575
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Bangor, ME
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Bedford Park, 5042
9342
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from
Bedford Park,
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1444
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Boston, MA
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1291
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from
Bronx, NY
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1287
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from
Brooklyn, NY
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1255
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Browns Mills, NJ
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966
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from
Bryn Mawr, PA
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1438
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from
Burlington, MA
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1356
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from
Burlington, VT
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1043
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Chapel Hill, NC
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719
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from
Chattanooga, TN
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440
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from
Cheyenne, WY
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610
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from
Chicago, IL
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1140
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from
Chula Vista, CA
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726
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from
Cincinnati, OH
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972
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Columbia, SC
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810
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from
Columbus, OH
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841
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from
Detroit, MI
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1288
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Englewood, NJ
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754
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Fairhope, AL
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Fall River, Massachusetts 02720
1437
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from
Fall River, MA
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635
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from
Fargo, ND
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1296
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from
Flushing, NY
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715
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from
Fort Wayne, IN
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346
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from
Fort Worth, TX
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609
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from
Galveston, TX
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Greensboro, North Carolina 27401
1002
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from
Greensboro, NC
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Greenville, North Carolina 27834
1139
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from
Greenville, NC
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Greenville, South Carolina 29605
882
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from
Greenville, SC
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1285
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from
Hackensack, NJ
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1176
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from
Inglewood, CA
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429
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from
Iowa City, IA
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578
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from
Joliet, IL
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1098
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from
Kalispell, MT
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196
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from
Kansas City, KS
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1238
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from
Langhorne, PA
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725
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from
Lexington, KY
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630
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Milwaukee, WI
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Mission Viejo, California 92691
1147
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from
Mission Viejo, CA
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1284
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from
Neptune, NJ
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697
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from
New Orleans, LA
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1290
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from
New York, NY
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1181
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from
Norfolk, VA
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1139
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from
Orlando, FL
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787
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from
Pensacola, FL
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1225
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from
Philadelphia, PA
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Rancho Mirage, California 90070
1177
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Rancho Mirage, CA
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403
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from
Saint Charles, MO
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418
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from
Saint Louis, MO
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779
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from
Salt Lake City, UT
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583
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from
San Antonio, TX
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1201
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from
Spokane, WA
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251
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from
Springfield, MO
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1117
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from
Tampa, FL
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541
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from
The Woodlands, TX
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805
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from
Toledo, OH
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561
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from
Tupelo, MS
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1299
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from
Valhalla, NY
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1421
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from
Warwick, RI
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1127
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from
Washington,
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976
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from
Winston-Salem, NC
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1405
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from
Worcester, MA
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1219
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from
Wynnewood, PA
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810
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from
Ypsilanti, MI
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