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 |
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).
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
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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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University of Utah Research is a major component in the life of the U benefiting...
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Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Charleston, South Carolina 29425
Principal Investigator: Frank Cuoco
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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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
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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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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600 Gresham Dr
Norfolk, Virginia 23507
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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3451 Walnut St
Philadelphia, Pennsylvania 19104
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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Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Richmond, Virginia 23298
Principal Investigator: Richard Shepard
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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110 Irving St NW
Washington, District of Columbia 20010
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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