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QP ExCELs (CRT-DX) Clinical Trial

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 Results

Key Result 1

Significantly Lower Rate of Major Complications with CRT-DX

QP Excel study Key Result 1

With CRT-DX, significantly fewer patients experience major complications.

Key Result 2

Fewer Lead Dislodgements with CRT-DX and Similar Performance of RV Lead

QP Excel study Key Result 2

Key Results

Key Result 3

Similar CRT Responses Shown in LV Pacing and Clinical Outcome Parameters

QP Excel (CRT-DX) study Key Result 3

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 Details

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

Main Exclusion Criteria

  • Permanent atrial fibrillation

Devices

  • ICD and CRT-D

Study Flowchart

QP Excel 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)

Principal Investigators

  • Prof. Dr. Gerhard Hindricks, Herzzentrum Leipzig, Germany

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1 Brignole M et al. 2013 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy. European Heart Journal. 2013, 34(29).