©2022 Stanford Medicine
AdaptResponse Clinical Trial
Recruiting
Trial ID: NCT02205359
Purpose
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).
Official Title
AdaptResponse Clinical Trial
Stanford Investigator(s)
Mohan Viswanathan
Clinical Professor, Medicine - Cardiovascular Medicine
Eligibility
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.
Intervention(s):
device: aCRT ON
device: aCRT OFF
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Linda Norton, RN, MSN
(650) 725-5597