Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:December 13, 2017
End Date:July 2020

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Prospective, multi-center, single arm, post approval study to be conducted in the United
States.

Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite
Pacing) feature in the Resonate family of CRT-D devices1 and confirm safety in a post
approval study when used in accordance with its approved labeling.

Inclusion Criteria:

1. Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices
with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family
of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD
implantation is allowed.

2. Subjects must meet BSC labeled indication for CRT-D implantation.

3. Subjects must have a functional RA lead and RV lead implanted

4. Subjects who are willing and capable of providing informed consent

5. Subjects who are willing and capable of participating in all testing/visits associated
with this clinical study at an approved clinical study center and at the intervals
defined by this protocol

6. Subjects who are age 18 and above, or of legal age to give informed consent specific
to state and national law

Exclusion Criteria:

1. Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system
implantation.

2. Subjects who received the LV MSP therapy post CRT-D implantation but prior to
enrollment

3. Subjects with documented history of permanent AF

4. Subjects with documented permanent complete AV block

5. Subjects who are expected to receive a heart transplant during the 12 months course of
the study

6. Subjects with documented life expectancy of less than 12 months

7. Subjects who enrolled in any other concurrent study or registry, with the exception of
mandatory national or governmental registry, without prior written approval from BSC
We found this trial at
57
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
Principal Investigator: Mark Richards
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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3550 Jerome Avenue
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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201 Presidents Circle
Salt Lake City, Utah 84108
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800 North Fant Street
Anderson, South Carolina 29621
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Arcadia, California 91007
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Augusta, Georgia 30912
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Bedford, Texas 76021
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801 North 29th Street
Billings, Montana 59107
406-238-2500
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Boston, Massachusetts 02135
Principal Investigator: Michael Orlov
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Browns Mills, New Jersey 08015
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Charlottesville, Virginia 22903
(434) 924-0311
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Chula Vista, California 91910
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Cincinnati, Ohio 45220
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
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Delray Beach, Florida 33431
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22101 Moross Road
Detroit, Michigan 48236
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508 Fulton Street
Durham, North Carolina 27705
919-286-0411
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Germantown, Tennessee 38138
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1 Genesys Pkwy
Grand Blanc, Michigan 48439
(810) 606-5000
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Hackensack, New Jersey 07601
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Houston, Texas 77030
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Huntington, West Virginia 25702
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Jackson, Mississippi 39216
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3901 Rainbow Blvd
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(913) 588-5000
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Lake Mary, Florida 32746
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4733 Sunset Blvd
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6420 Dutchmans Parkway
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7617 Little River Turnpike
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Mobile, Alabama 36607
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Norfolk, Virginia 23507
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1100 North Palm Canyon Drive
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