Clinical Trial: CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: CRT Implant Strategy Using the Longest Electrical Delay for Non-left Bundle Branch Block Patients (ENHANCE CRT). A Prospective, Randomized, Postmarket, Pilot Study.

Brief Summary: The purpose of this study is to analyze the effect of left ventricular (LV) lead pacing location in the non-left bundle branch block (NLBBB)heart failure (HF) patient population. The LV lead pacing location will be guided by either the pacing site with the largest amount of dyssynchrony as measured by the LV electrical delay (QLV) or the physician's standard of care implant approach.

Detailed Summary:
Sponsor: St. Jude Medical

Current Primary Outcome: Improved Clinical Composite Score [ Time Frame: 12 months ]

Evaluate the Clinical composite score at 12 months in NLBBB patients using a standard of care versus latest electrical delay (QLV) based implant strategy. The Clinical composite score includes 4 components: New York Heart Association (NYHA)class, Patient Global Assessment (PGA), HF events, and cardiovascular death.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Jude Medical

Dates:
Date Received: October 31, 2013
Date Started: November 2013
Date Completion:
Last Updated: August 25, 2016
Last Verified: August 2016