Model 4396 Left Ventricular (LV) Lead Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/20/2019
Start Date:March 2009
End Date:August 2010

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Model 4396 Left Ventricular Lead Study

This study is designed to show that a new lead, which paces the left bottom chamber (left
ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart
has been shown to potentially improve heart failure symptoms. The shape and size of this new
lead may make it a good choice for patients or physicians.

This study is a prospective, multi-center, non-randomized design. All consented patients who
meet all inclusion and no exclusion criteria may receive the investigational lead. The study
design has statistical power to show safety at one-month after implant. It also has
statistical power to show effectiveness at one-month and three-months after implant.

Inclusion Criteria:

- CRT/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications, New York
Heart Association (NYHA) III and IV, indicated for implantable cardiac defibrillator
(ICD) if CRT-D is implanted, patient consent, geographically stable

Exclusion Criteria:

- LV lead implant attempt in last 30 days, unstable angina or acute myocardial
infarction (MI) in past 30 days, coronary artery bypass graft (CABG) or percutaneous
transluminal coronary angioplasty (PTCA) in past 3 months, contraindicated for
transvenous pacing, heart transplant
We found this trial at
20
sites
827
mi
from 91732
Portland, OR
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1919
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from 91732
Atlanta, GA
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2305
mi
from 91732
Atlantis, FL
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1213
mi
from 91732
Austin, TX
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1589
mi
from 91732
Baton Rouge, LA
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7952
mi
from 91732
Bendigo,
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1576
mi
from 91732
Davenport, IA
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2202
mi
from 91732
Durham, NC
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1713
mi
from 91732
Hinsdale, IL
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1339
mi
from 91732
Kansas City, KS
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1881
mi
from 91732
Lexington, KY
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2315
mi
from 91732
Liverpool, NY
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2122
mi
from 91732
Morgantown, WV
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1763
mi
from 91732
Nashville, TN
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2435
mi
from 91732
New York, NY
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9
mi
from 91732
Pasadena, CA
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364
mi
from 91732
Sacramento, CA
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1505
mi
from 91732
Saint Louis Park, MN
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1516
mi
from 91732
Saint Paul, MN
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2299
mi
from 91732
York, PA
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