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 Results

Key Result 1

Significantly fewer inappropriate ICD therapies with DX technology

KURT-Key Result1

KURT-Key result 1

The incidence of inappropriate ICD therapy was lower with DX, even though a previous history of AF was more frequent in the DX group.

 

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

KURT Key result 2

Key Result 3

KURT study - 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

Link to Publication

Avoiding inappropriate therapy of single-lead implantable cardioverter-defibrillator by using atrial-sensing electrodes

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Kurt Leaflet

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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