QP ExCELs CRT DX

QP ExCELs (CRT-DX)

Novel Two-Lead Cardiac Resynchronization Therapy System Provides Equivalent CRT Responses with Less Complications than a Conventional Three-Lead System: Results from the QP ExCELs Lead Registry

Shaik N et al., Journal of Cardiovascular Electrophysiology, May 2020.
doi: 10.1111/jce.14552


Study Design

  • Subanalysis of QP ExCELs (prospective, multi-center, observational international registry to evaluate the safety and efficacy of the Sentus QP LV lead in 1907 patients)
  • Comparing complication rates and CRT response: two-lead CRT-DX vs. standard CRT-D system
  • Including 240 de novo patients with standard CRT indication from 50 U.S. centers (120 pairs matched by gender, NYHA class, and heart failure etiology)

Key Result 1

Significantly Lower Rate of Major Complications with CRT-DX

Image

Key Result 2

Lead-Related Major Complications:
Fewer Lead Dislodgements with CRT-DX and Similar Performance of RV Lead

Image

Key Result 3

Similar CRT Responses Shown in LV Pacing and Clinical Outcome Parameters

Image

Clinical Relevance

  • First study to compare major complications in CRT-DX systems with standard CRT-D systems in a multi-center, real-life registry
  • The results show that the CRT-DX system can provide similar CRT responses and significantly fewer complications, indicating that the CRT-DX system is a capable alternative in patients without an atrial pacing indication.2

2 Author’s conclusion extracted from publication.

 


Study Objective
  • To compare complication rates and CRT response between subjects with a two-lead CRT-DX system and those with a standard three-lead CRT-D system
Primary Endpoint
  • Freedom from major complications, defined as events related or possibly related to the implanted system or the implant procedure and requiring invasive intervention to resolve.

Additional Data of Interest

CRT device performance and response:

  • LV pacing during CRT
  • Inappropriate shocks
  • Patient activity
  • NYHA class change
  • Heart failure hospitalization
  • All-cause mortality
Clinical Sites
  • 50 U.S. centers
Sample Size
  • 240 patients
Main Inclusion Criteria
  • Standard CRT-D indication
  • De novo implants
  • Patients selected from QP ExCELs registry with a minimum of 6 months of possible follow-up time

 

Study Flowchart
Follow-Up

Mean follow-up

  • 1.3 years (CRT-DX)
  • 1.4 years (CRT-D)
Study Duration
  •  06/2017 – 01/2020
Reference no.
  • NCT02290028 (QP ExCELs)