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

Use our guide to learn which trials are right for you!

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
Columbus, Ohio 43213
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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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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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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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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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Ypsilanti, Michigan 48197
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