AdaptResponse Clinical Trial

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).

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • device: aCRT ON
  • device: aCRT OFF

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linda Norton, RN, MSN
(650) 725-5597
Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.