Description

AdaptivCRT® (aCRT) algorithm CRT devices in reducing incidence of the combined endpoint of all-cause mortality and intervention for heart failure decompensation compared to standard CRT therapy

Principal Investigator:  John Seger, M.D.

Sponsor:  Medtronic, Inc.

The aCRT algorithm has been developed to provide RV-synchronized LV pacing when intrinsic AV conduction is normal or BiV pacing otherwise. The algorithm also adjusts AV and VV delays based on periodic automatic evaluation of intrinsic conduction intervals. The algorithm is intended to provide ambulatory CRT optimization and allow more physiologic ventricular activation and greater device longevity in patients with normal AV conduction by reducing unnecessary RV pacing.

Main Inclusion Criteria:

  1. Sinus rhythm at time of enrollment
  2. Left Bundle Branch Block (LBBB) as documented on an ECG
  3. Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or equal to 200ms
  4. Left ventricular ejection fraction less than or equal to 35%
  5. NYHA class II, III or IV despite optimal medical therapy

Main Exclusion Criteria:

  1. 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.
  2. Subject is post heart transplant (subjects on the heart transplant list for the first time are not excluded).

Contact

Stephen Harold harold@bcm.eduPhone 1: (713) 798-1037
IRB: h-38200

Status

Active

Created

Jul 01, 2016