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 |
Prospective, multi-center, single arm, post approval study to be conducted in the United
States.
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.
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
sites
7617 Little River Turnpike
Manassas, Virginia 22003
Manassas, Virginia 22003
Principal Investigator: Aysha Arshad
Phone: 703-335-8750
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330 Brookline Ave
Boston, Massachusetts 02215
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Peter Zimetbaum
Phone: 617-667-8800
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Luigi Di Biase
Phone: 718-920-4116
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
Fort Sam Houston, Texas 78234
(210) 916-4141
Principal Investigator: Gregg Gerasimon
Phone: 210-916-0907
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Jay Montgomery
Phone: 615-343-8047
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Benjamin Steinberg
Phone: 801-585-1935
University of Utah Research is a major component in the life of the U benefiting...
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800 North Fant Street
Anderson, South Carolina 29621
Anderson, South Carolina 29621
Principal Investigator: Rick Alan
Phone: 864-512-4530
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Arcadia, California 91007
Principal Investigator: Jesus Vazquez
Phone: 626-254-0074
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Augusta, Georgia 30912
Principal Investigator: Haitham Hreibe
Phone: 706-721-2736
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9000 Franklin Square Drive
Baltimore, Maryland 21237
Baltimore, Maryland 21237
Principal Investigator: Glenn Meininger
Phone: 443-777-2369
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801 North 29th Street
Billings, Montana 59107
Billings, Montana 59107
406-238-2500
Principal Investigator: Loren Budge
Phone: 406-435-7415
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Boston, Massachusetts 02135
Principal Investigator: Michael Orlov
Phone: 617-789-3187
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Browns Mills, New Jersey 08015
Principal Investigator: Raffaele Corbisiero
Phone: 609-893-8611
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Andrew Darby
Phone: 434-924-0393
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Chula Vista, California 91910
Principal Investigator: Brett Berman
Phone: 619-934-3260
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Cincinnati, Ohio 45220
Principal Investigator: Marshall Winner
Phone: 513-862-2877
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410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Toshimasa Okabe
Phone: 614-293-4967
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Delray Beach, Florida 33431
Principal Investigator: Yoel Vivas
Phone: 561-303-3491
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22101 Moross Road
Detroit, Michigan 48236
Detroit, Michigan 48236
Principal Investigator: Sohail Hassan
Phone: 313-343-4811
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508 Fulton Street
Durham, North Carolina 27705
Durham, North Carolina 27705
919-286-0411
Principal Investigator: Albert Sun
Phone: 919-416-5893
Durham VA Medical Center Since 1953, Durham Veterans Affairs Medical Cetner has been improving the...
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Elk Grove Village, Illinois 60007
Principal Investigator: Mohammed Khan
Phone: 847-981-3680
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Fort Wayne, Indiana 46805
Principal Investigator: David Schleinkofer
Phone: 260-266-5600
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Germantown, Tennessee 38138
Principal Investigator: Jeffrey Kerlan
Phone: 901-271-1000
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1 Genesys Pkwy
Grand Blanc, Michigan 48439
Grand Blanc, Michigan 48439
(810) 606-5000
Principal Investigator: Karl IIg
Phone: 810-606-7713
Genesys Regional Medical Center Genesys Health System, a member of Ascension Health, is a group...
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Hackensack, New Jersey 07601
Principal Investigator: John Zimmerman
Phone: 551-996-2000
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Huntington, West Virginia 25702
Principal Investigator: Esam Baryun
Phone: 304-399-7548
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Jackson, Mississippi 39216
Principal Investigator: Takeki Suzuki
Phone: 601-984-5678
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Jacksonville, Florida 32209
Principal Investigator: John Catanzaro
Phone: 904-244-4660
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Jonesboro, Arkansas 72401
Principal Investigator: Devi Nair
Phone: 870-935-6729
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3901 Rainbow Blvd
Kansas City, Kansas 66160
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Rhea Pimentel
Phone: 913-558-9600
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Kansas City, Missouri 64111
Principal Investigator: Brian Ramza
Phone: 816-931-1883
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Lake Mary, Florida 32746
Principal Investigator: Jorge Diaz
Phone: 407-444-4848
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4733 Sunset Blvd
Los Angeles, California 90027
Los Angeles, California 90027
(800) 954-8000
Principal Investigator: Nigel Gupta
Phone: 323-783-5352
Kaiser Permanente Los Angeles Medical Center We've been there for you in the past, providing...
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6420 Dutchmans Parkway
Louisville, Kentucky 40205
Louisville, Kentucky 40205
Principal Investigator: Robert Schwartz
Phone: 502-891-8641
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New Haven, Connecticut 06520
Principal Investigator: Jude Clancy
Phone: 203-737-7695
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Norfolk, Virginia 23507
Principal Investigator: Allen Ciuffo
Phone: 757-388-2425
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Omaha, Nebraska 68114
Principal Investigator: Matthew Latacha
Phone: 402-384-2705
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1100 North Palm Canyon Drive
Palm Springs, California 92262
Palm Springs, California 92262
Principal Investigator: Hetal Bhakta
Phone: 760-883-1600
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Philadelphia, Pennsylvania
Principal Investigator: John Bullinga
Phone: 215-662-9000
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Phoenix, Arizona
Principal Investigator: Ashish Sadhu
Phone: 602-307-0070
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Sandeep Jain
Phone: 412-647-6272
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Rapid City, South Dakota 75501
Principal Investigator: Jose Teixeira
Phone: 605-755-4326
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Saginaw, Michigan 48601
Principal Investigator: Asim Yunus
Phone: 989-754-3555
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Shreveport, Louisiana
Principal Investigator: Sherman Wiggins
Phone: 318-798-9400
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Tacoma, Washington 98405
Principal Investigator: Nasir Shariff
Phone: 253-426-6882
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Tallahassee, Florida 32308
Principal Investigator: Marilyn Cox
Phone: 850-431-5024
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2142 N Cove Blvd
Toledo, Ohio 43606
Toledo, Ohio 43606
(419) 291-4000
Principal Investigator: Mark Richards
Phone: 419-842-3000
Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
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Urbana, Illinois 61801
Principal Investigator: Benjamin Rhee
Phone: 217-383-6622
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Ventura, California 93003
Principal Investigator: Jonathan Dukes
Phone: 805-653-0101
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Wormleysburg, Pennsylvania 17043
Principal Investigator: Chinmay Patel
Phone: 717-731-0101
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Wyomissing, Pennsylvania 19610
Principal Investigator: Louis Borgatta
Phone: 610-685-4879
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Youngstown, Ohio 44501
Principal Investigator: Allan Katz
Phone: 330-726-3204
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