Key Results
Key Result 1
Significantly fewer inappropriate ICD therapies with DX technology
The incidence of inappropriate ICD therapy was lower with DX, even though a previous history of AF was more frequent in the DX group.
Kurt et al. (2018) Clinical Trial
Avoiding inappropriate therapy of single‐lead implantable cardioverter‐defibrillator by using atrial‐sensing electrodes
Kurt M et al., Journal of Cardiovascular Electrophysiology, September 2018. doi: 10.1111/jce.13736
Investigator-initiated trial, not funded by BIOTRONIK
Study Design
Prospective, single-center, non-randomized study
Key Result 2
It Does Not Take Longer to Implant a DX System Than a VVI
No significant differences in fluoroscopic burden and operative duration between in th DX group and the VVI group
Key Result 3
Clinical Relevance
- Use of single-chamber ICDs can result in significant adverse events, such as inappropriate ICD therapies most commonly caused by AF and supraventricular tachyarrhythmias
- It has been well known that the incidence of inappropriate ICD therapy is associated with poor patient outcomes
- The efficacy of the DX-ICD system for preventing inappropriate ICD therapies may lead to improvements not only in the quality of life, but also possibly in the prognosis of the patients
Study Details
Study Objective
- To investigate whether the use of a single-lead ICD system with atrial-sensing electrodes (DX technology) results in a reduction of inappropriate ICD therapy compared to standard single-chamber ICDs (VVI)
Primary Endpoint
- Occurrence of inappropriate ICD therapy including ATP and shock
Secondary Endpoint
- Occurrence of appropriate ICD therapy
Clinical Sites
- Heinrich Heine University Düsseldorf, Germany
Sample Size
- 212 consecutive patients who underwent primary prophylactic single-lead ICD implantation or replacement (77 patients with DX-ICD and 135 with VVI-ICD)
Main Inclusion Criteria
-
Consecutive patients undergoing primary prophylactic single-lead ICD implantation or replacement at the institute in the context of Düsseldorf University Device Registry
-
ICD replacement: patients with single-lead ICD and no previously documented ventricular tachycardia/ventricular fibrillation (VT/VF) or ICD therapies including antitachycardia pacing (ATP) and shock
-
Indication for ICD: based on classes I and IIa recommendations from the 2015 European Society of Cardiology Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death1
Main Exclusion Criteria
- Patients with a previous history of sick sinus syndrome, atrioventricular block, or syncope
Products
-
DX-ICD implantation: Lumax VR-T DX, Iforia VR-T DX, or Itrevia VR-T DX device, combined with Linox Smart S DX or Linox Smart ProMRI S DX lead
-
VVI-ICD implantation: selection of device at implanter’s discretion
Follow-Up
- 12 months after randomization
Reference no.
- NCT00538356
Related Link and Download
1 Priori SG, Blomström‐Lundqvist C, Mazzanti A, et al. Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: the Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC) Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC). Europace. 2015;17:1601‐1687