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
	
								Tacoma, Washington 98405			
	
			
					Principal Investigator: Nasir Shariff
			
						
										Phone: 253-426-6882
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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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									7617 Little River Turnpike
Manassas, Virginia 22003
	
			
					Manassas, Virginia 22003
Principal Investigator: Aysha Arshad
			
						
										Phone: 703-335-8750
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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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								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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