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
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...
Click here to add this to my saved trials

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...
Click here to add this to my saved trials

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...
Click here to add this to my saved trials

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!...
Click here to add this to my saved trials

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...
Click here to add this to my saved trials

800 North Fant Street
Anderson, South Carolina 29621
Anderson, South Carolina 29621
Principal Investigator: Rick Alan
Phone: 864-512-4530
Click here to add this to my saved trials

Arcadia, California 91007
Principal Investigator: Jesus Vazquez
Phone: 626-254-0074
Click here to add this to my saved trials

Augusta, Georgia 30912
Principal Investigator: Haitham Hreibe
Phone: 706-721-2736
Click here to add this to my saved trials

9000 Franklin Square Drive
Baltimore, Maryland 21237
Baltimore, Maryland 21237
Principal Investigator: Glenn Meininger
Phone: 443-777-2369
Click here to add this to my saved trials

Click here to add this to my saved trials

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...
Click here to add this to my saved trials

Boston, Massachusetts 02135
Principal Investigator: Michael Orlov
Phone: 617-789-3187
Click here to add this to my saved trials

Browns Mills, New Jersey 08015
Principal Investigator: Raffaele Corbisiero
Phone: 609-893-8611
Click here to add this to my saved trials

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...
Click here to add this to my saved trials

Chula Vista, California 91910
Principal Investigator: Brett Berman
Phone: 619-934-3260
Click here to add this to my saved trials

Cincinnati, Ohio 45220
Principal Investigator: Marshall Winner
Phone: 513-862-2877
Click here to add this to my saved trials

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...
Click here to add this to my saved trials

Delray Beach, Florida 33431
Principal Investigator: Yoel Vivas
Phone: 561-303-3491
Click here to add this to my saved trials

22101 Moross Road
Detroit, Michigan 48236
Detroit, Michigan 48236
Principal Investigator: Sohail Hassan
Phone: 313-343-4811
Click here to add this to my saved trials

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...
Click here to add this to my saved trials

Elk Grove Village, Illinois 60007
Principal Investigator: Mohammed Khan
Phone: 847-981-3680
Click here to add this to my saved trials

Fort Wayne, Indiana 46805
Principal Investigator: David Schleinkofer
Phone: 260-266-5600
Click here to add this to my saved trials

Germantown, Tennessee 38138
Principal Investigator: Jeffrey Kerlan
Phone: 901-271-1000
Click here to add this to my saved trials

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...
Click here to add this to my saved trials

Hackensack, New Jersey 07601
Principal Investigator: John Zimmerman
Phone: 551-996-2000
Click here to add this to my saved trials

Click here to add this to my saved trials

Huntington, West Virginia 25702
Principal Investigator: Esam Baryun
Phone: 304-399-7548
Click here to add this to my saved trials

Jackson, Mississippi 39216
Principal Investigator: Takeki Suzuki
Phone: 601-984-5678
Click here to add this to my saved trials

Jacksonville, Florida 32209
Principal Investigator: John Catanzaro
Phone: 904-244-4660
Click here to add this to my saved trials

Jonesboro, Arkansas 72401
Principal Investigator: Devi Nair
Phone: 870-935-6729
Click here to add this to my saved trials

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...
Click here to add this to my saved trials

Kansas City, Missouri 64111
Principal Investigator: Brian Ramza
Phone: 816-931-1883
Click here to add this to my saved trials

Lake Mary, Florida 32746
Principal Investigator: Jorge Diaz
Phone: 407-444-4848
Click here to add this to my saved trials

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...
Click here to add this to my saved trials

6420 Dutchmans Parkway
Louisville, Kentucky 40205
Louisville, Kentucky 40205
Principal Investigator: Robert Schwartz
Phone: 502-891-8641
Click here to add this to my saved trials

7617 Little River Turnpike
Manassas, Virginia 22003
Manassas, Virginia 22003
Principal Investigator: Aysha Arshad
Phone: 703-335-8750
Click here to add this to my saved trials

Click here to add this to my saved trials

New Haven, Connecticut 06520
Principal Investigator: Jude Clancy
Phone: 203-737-7695
Click here to add this to my saved trials

Norfolk, Virginia 23507
Principal Investigator: Allen Ciuffo
Phone: 757-388-2425
Click here to add this to my saved trials

Omaha, Nebraska 68114
Principal Investigator: Matthew Latacha
Phone: 402-384-2705
Click here to add this to my saved trials

1100 North Palm Canyon Drive
Palm Springs, California 92262
Palm Springs, California 92262
Principal Investigator: Hetal Bhakta
Phone: 760-883-1600
Click here to add this to my saved trials

Philadelphia, Pennsylvania
Principal Investigator: John Bullinga
Phone: 215-662-9000
Click here to add this to my saved trials

Phoenix, Arizona
Principal Investigator: Ashish Sadhu
Phone: 602-307-0070
Click here to add this to my saved trials

Pittsburgh, Pennsylvania 15213
Principal Investigator: Sandeep Jain
Phone: 412-647-6272
Click here to add this to my saved trials

Click here to add this to my saved trials

Rapid City, South Dakota 75501
Principal Investigator: Jose Teixeira
Phone: 605-755-4326
Click here to add this to my saved trials

Saginaw, Michigan 48601
Principal Investigator: Asim Yunus
Phone: 989-754-3555
Click here to add this to my saved trials

Click here to add this to my saved trials

Shreveport, Louisiana
Principal Investigator: Sherman Wiggins
Phone: 318-798-9400
Click here to add this to my saved trials

Tacoma, Washington 98405
Principal Investigator: Nasir Shariff
Phone: 253-426-6882
Click here to add this to my saved trials

Tallahassee, Florida 32308
Principal Investigator: Marilyn Cox
Phone: 850-431-5024
Click here to add this to my saved trials

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...
Click here to add this to my saved trials

Urbana, Illinois 61801
Principal Investigator: Benjamin Rhee
Phone: 217-383-6622
Click here to add this to my saved trials

Ventura, California 93003
Principal Investigator: Jonathan Dukes
Phone: 805-653-0101
Click here to add this to my saved trials

Wormleysburg, Pennsylvania 17043
Principal Investigator: Chinmay Patel
Phone: 717-731-0101
Click here to add this to my saved trials

Wyomissing, Pennsylvania 19610
Principal Investigator: Louis Borgatta
Phone: 610-685-4879
Click here to add this to my saved trials

Youngstown, Ohio 44501
Principal Investigator: Allan Katz
Phone: 330-726-3204
Click here to add this to my saved trials
