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
Mesa, Arizona 85206
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
455 Pinellas St., Suite 330
Clearwater, Florida 33756
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
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...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Albuquerque, New Mexico 87106
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
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...
?
mi
from
Allentown, PA
Click here to add this to my saved trials
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...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheville, North Carolina
?
mi
from
Asheville, NC
Click here to add this to my saved trials
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...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21237
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bridgeport, Connecticut 06610
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
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...
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Burlington, Vermont 05405
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Camp Hill, Pennsylvania 17011
?
mi
from
Camp Hill, PA
Click here to add this to my saved trials
Charleston, South Carolina 29425
Principal Investigator: Frank Cuoco
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, West Virginia 25304
?
mi
from
Charleston, WV
Click here to add this to my saved trials
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80933
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
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...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43214
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Elyria, OH
Click here to add this to my saved trials
Eugene, Oregon 97401
?
mi
from
Eugene, OR
Click here to add this to my saved trials
350 Northwest 84th Avenue
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Gainesville, Florida 32605
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
High Point, North Carolina
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77024
?
mi
from
Houston, TX
Click here to add this to my saved trials
6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
Kansas City, Missouri
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
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...
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Lansing, Michigan 48912
?
mi
from
Lansing, MI
Click here to add this to my saved trials
Little Rock, Arkansas
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Loveland, Colorado 80538
?
mi
from
Loveland, CO
Click here to add this to my saved trials
Memphis, Tennessee
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53215
Principal Investigator: Atul Bhatia
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
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...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
University of Minnesota Medical Center, Fairview Improving patients' lives drives the innovation that makes University...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Montgomery, Alabama 36116
?
mi
from
Montgomery, AL
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Lambton, New South Wales 2305
?
mi
from
New Lambton,
Click here to add this to my saved trials
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...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
Newtown, Pennsylvania 18940
?
mi
from
Newtown, PA
Click here to add this to my saved trials
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...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73120
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Overland Park, Kansas
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Panama City, FL
Click here to add this to my saved trials
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Plano, Texas 75093
?
mi
from
Plano, TX
Click here to add this to my saved trials
Poughkeepsie, New York 12601
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
Raleigh, North Carolina
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Richmond, Virginia 23298
Principal Investigator: Richard Shepard
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Richmond, Virginia 23225
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Robbinsdale, MN
Click here to add this to my saved trials
?
mi
from
Rockford, IL
Click here to add this to my saved trials
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...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
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...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Paul, Minnesota 55102
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
San Jose, California 95124
?
mi
from
San Jose, CA
Click here to add this to my saved trials
Scranton, Pennsylvania 18510
?
mi
from
Scranton, PA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Spokane, Washington
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Springfield, Illinois 62701
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Stockton, California
Principal Investigator: Chien Walter
?
mi
from
Stockton, CA
Click here to add this to my saved trials
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...
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
The Woodlands, Texas 77384
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
Troy, Michigan 48085
?
mi
from
Troy, MI
Click here to add this to my saved trials
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Utica, New York 13501
?
mi
from
Utica, NY
Click here to add this to my saved trials
Voorhees, New Jersey 08043
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
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...
?
mi
from
Washington,
Click here to add this to my saved trials
Ypsilanti, Michigan 48197
?
mi
from
Ypsilanti, MI
Click here to add this to my saved trials