Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:9/5/2018
Start Date:March 2014
End Date:September 2022

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Evaluation of ACUITY™ X4 Quadripolar Coronary Venous Leads and RELIANCE™ 4-FRONT Defibrillation Leads: NAVIGATE X4

The objective of the NAVIGATE X4 Clinical Study is to gather data to establish the safety,
performance and effectiveness of the ACUITY™ X4 quadripolar coronary venous leads and the
RELIANCE 4-FRONT™ ventricular defibrillation leads to satisfy FDA requirements for pre-market
submission. Additionally, data from this study will be used to support post-market approval
requirements for the ACUITY X4 and RELIANCE 4-FRONT leads.


Inclusion Criteria:

Subjects indicated for a CRT-D that fulfill one of the following 5 criteria[1]:

1. Subject with LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration
greater than or equal to 150 ms, and a NYHA class II, III or ambulatory IV symptoms on
GDMT*

2. Subject with LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration
120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT*

3. Subject with LVEF less than or equal to 35%, sinus rhythm, a non-LBBB pattern with a
QRS duration greater than or equal to 150 ms, and NYHA class III/ ambulatory class IV
symptoms on GDMT*

4. Subject with atrial fibrillation and LVEF less than or equal to 35% on GDMT* if a) the
subject requires ventricular pacing or otherwise meets CRT criteria [listed here] and
b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular
pacing with CRT

5. Subject on GDMT* who have LVEF less than or equal to 35% and are undergoing new device
placement with anticipated requirement for significant (>40%) ventricular pacing *GDMT
= Guideline-directed medical therapy (formerly known as optimal pharmaceutical therapy
(OPT)), represents optimal medical therapy as defined by ACCF/ AHA
guideline-recommended therapies (primarily Class I)

- Subject is intended to receive the ACUITY X4 LV lead and RELIANCE 4-FRONT RV lead
(optional in Study Phase 1) and BSC CRT-D with quad header as their initial (de
novo) cardiac implants

- Subject is willing and capable of providing informed consent (which can include
the use of a legally authorized representative (LAR) for documentation of
informed consent) and participating in all testing associated with this
investigation at an approved center and at the intervals defined by this protocol

- Subject is age 18 or above, or of legal age to give informed consent specific to
state and national law

Exclusion Criteria:

Subjects who meet any one of the following criteria will be excluded from this clinical
study.

- Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)

- Subject has a mechanical tricuspid heart valve

- Subject is enrolled in any other concurrent study, with the exception of local
mandatory governmental registries and observational studies/registries* that are not
in conflict and do not affect the following:

- Schedule of procedures for the Study (i.e. should not cause additional or missed
visits);

- Study outcome (i.e. involve medications that could affect the heart rate of the
subject);

- Conduct of the Study per GCP/ ISO 14155:2011/ 21 CFR 812, local regulations

- Subject is currently on the active heart transplant list

- Subject has a documented life expectancy of less than twelve months

- Women of childbearing potential who are or might be pregnant at the time of study
enrollment or CRT-D System implant (method of assessment upon physician's discretion)

- Subjects currently requiring chronic dialysis *Sponsors of such studies/registries
should be informed and Boston Scientific must be informed by the investigator about
the parallel conduct of these projects in the subject and of the project's basic
nature. The decision if a desired mandatory governmental registry or observational
study/ registry is in conflict with this exclusion criterion is up to the enrolling
investigator.
We found this trial at
96
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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Anchorage, Alaska 99508
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Austin, Texas 78705
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Austin, Texas 78756
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Baltimore, Maryland
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489 State St
Bangor, Maine 04401
(207) 973-7000
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Bellingham, Washington 98225
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
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Browns Mills, New Jersey 08015
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Canton, Ohio 44710
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charleston, West Virginia 25304
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Cincinnati, Ohio 45220
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Columbia, Missouri 65201
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Dallas, Texas 75231
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Dyer, Indiana 46311
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Florence, South Carolina 29505
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5352 Linton Boulevard
Fort Lauderdale, Florida 33334
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Fort Wayne, Indiana 46804
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Grand Rapids, Michigan 49503
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1 Cooper Plaza
Haddon Heights, New Jersey 08035
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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Huntsville, Alabama 35801
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Indianapolis, Indiana 46260
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
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530 S Jackson St
Louisville, Kentucky 40202
502-562-3226
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Mechanicsville, Virginia 23116
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2825 East Barnett Road
Medford, Oregon 97504
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6750 East Baywood Avenue
Mesa, Arizona 85206
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Morgantown, West Virginia 26505
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Muncie, Indiana 47303
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
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Nashville, Tennessee 37205
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Neptune, New Jersey 07754
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
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270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
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350 Hawthorne Avenue
Oakland, California 94609
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9205 SW Barnes Rd
Portland, Oregon 97225
(503) 216-1234
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
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7401 Beaufont Springs Drive
Richmond, Virginia 23225
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
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Sacramento, California 95819
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1406 6th Avenue North
Saint Cloud, Minnesota 56303
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Saint Paul, Minnesota 55102
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7901 Frost Street
San Diego, California 92123
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Scottsdale, Arizona 85260
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Sioux Falls, South Dakota 57108
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
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Spokane, Washington 99204
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Springfield, Illinois 62701
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1 Medical Park
Steubenville, Ohio 43952
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Stony Brook, New York 11794
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Tallahassee, Florida 32308
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7000 Fannin Street
The Woodlands, Texas 77030
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-4000
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1540 Maple Road
Williamsville, New York 14221
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144 Genesee Street
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York, Pennsylvania 17315
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