Key Results
Key Result 1
Significantly Lower Rate of Major Complications with CRT-DX
With CRT-DX, significantly fewer patients experience major complications.
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 Result 2
Fewer Lead Dislodgements with CRT-DX and Similar Performance of RV Lead
Key Results
Key Result 3
Similar CRT Responses Shown in LV Pacing and Clinical Outcome Parameters
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
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
Related Link and Download
1 Brignole M et al. 2013 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy. European Heart Journal. 2013, 34(29).