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
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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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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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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