AdaptResponse Clinical Trial



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:8/22/2018
Start Date:July 2014
End Date:March 2023
Contact:AdaptResponse Trial Leader
Email:medtronicCRMtrials@medtronic.com

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The purpose of this clinical study is to test the hypothesis that market released Cardiac
Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a
superior outcome compared to standard CRT devices in CRT indicated patients with normal
atrio-ventricular (AV) conduction and left bundle branch block (LBBB).


Inclusion Criteria:

- Subject is willing to sign and date the study Patient Informed Consent Form.

- Subject is indicated for a CRT device according to local guidelines.

- Sinus Rhythm at time of enrollment

- Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior
to enrollment). Strauss Criteria used for LBBB.

- Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or
equal to 200ms (within 30 days prior to enrollment).

- Left ventricular ejection fraction less than or equal to 35% (documented within 180
days prior to enrollment).

- NYHA class II, III or IV (documented within 30 days prior to enrollment) despite
optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose
of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.

Exclusion Criteria:

- Subject is less than 18 years of age (or has not reached minimum age per local law).

- Subject is not expected to remain available for at least 2 years of follow-up visits.

- Subject has permanent atrial arrhythmias for which pharmacological therapy and/or
cardioversion have been unsuccessful or have not been attempted

- Subject is, or previously has been, receiving cardiac resynchronization therapy.

- Subject is currently enrolled or planning to participate in a potentially confounding
drug or device trial during the course of this study. Co-enrollment in concurrent
trials is only allowed when documented pre-approval is obtained from the Medtronic
study manager.

- Subject has unstable angina, or experienced an acute myocardial infarction (MI) or
received coronary artery revascularization (CABG) or coronary angioplasty (PTCA)
within 30 days prior to enrollment.

- Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair
or valve replacement during the course of the study.

- Subject is post heart transplant (subjects on the heart transplant list for the first
time are not excluded).

- Subject has a limited life expectancy due to non-cardiac causes that would not allow
completion of the study.

- Subject is pregnant (if required by local law, women of child-bearing potential must
undergo a pregnancy test within seven days prior to device implant).

- Subject meets any exclusion criteria required by local law.
We found this trial at
99
sites
110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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455 Pinellas St., Suite 330
Clearwater, Florida 33756
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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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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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Albuquerque, New Mexico 87106
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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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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Asheville, North Carolina
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, Georgia 30309
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Austin, Texas 78705
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Baltimore, Maryland 21237
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Bridgeport, Connecticut 06610
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Burlington, Vermont 05405
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Camp Hill, Pennsylvania 17011
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Charleston, South Carolina 29425
Principal Investigator: Frank Cuoco
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Charleston, West Virginia 25304
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Charlottesville, Virginia 22908
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Chattanooga, Tennessee
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Chicago, Illinois 60611
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Cincinnati, Ohio 45242
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Cincinnati, Ohio 45219
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Colorado Springs, Colorado 80933
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Columbus, Ohio 43213
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, Ohio 43214
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Durham, North Carolina 27710
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Eugene, Oregon 97401
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350 Northwest 84th Avenue
Fort Lauderdale, Florida 33308
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Gainesville, Florida 32605
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High Point, North Carolina
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Houston, Texas 77024
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Jacksonville, Florida 32216
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Kansas City, Missouri
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Lansing, Michigan 48912
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Little Rock, Arkansas
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Loveland, Colorado 80538
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Memphis, Tennessee
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Mesa, Arizona 85206
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Milwaukee, Wisconsin 53215
Principal Investigator: Atul Bhatia
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
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Montgomery, Alabama 36116
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New Lambton, New South Wales 2305
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10016
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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Newtown, Pennsylvania 18940
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: Jon Grammes
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Oklahoma City, Oklahoma 73120
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Overland Park, Kansas
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: David Frankel, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Plano, Texas 75093
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Poughkeepsie, New York 12601
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Raleigh, North Carolina
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Richmond, Virginia 23298
Principal Investigator: Richard Shepard
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Richmond, Virginia 23225
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Robbinsdale, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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Saint Paul, Minnesota 55102
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San Jose, California 95124
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Scranton, Pennsylvania 18510
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Spokane, Washington
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Springfield, Illinois 62701
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Stanford, California 94305
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Stockton, California
Principal Investigator: Chien Walter
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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The Woodlands, Texas 77384
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Troy, Michigan 48085
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Utica, New York 13501
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Voorhees, New Jersey 08043
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Ypsilanti, Michigan 48197
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