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THINGS Clinical Trial

The Role of Atrial Sensing for New-Onset Atrial Arrhythmias Diagnosis and Management in Single-Chamber Implantable Cardioverter Defibrillator Recipients: Results From the THINGS Registry

BIFFI M ET AL., JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY 2020
doi: 10.1111/jce.14396

Study Design

  • Prospective, observational, multi-center study (15 centers in Italy), based on a patient selection of the THINGS registry
  • To explore whether a single-lead ICD with an atrial dipole (ICD DX) improves AT/AF diagnosis and management as compared to standard single-chamber ICD (ICD VR)
  • 376 patients (140 ICD DX and 236 ICD VR) with standard ICD indication and without history of AT/AF

Key Results

Key Result 1

Incidence of AT/AF Diagnosis: Significantly Higher with ICD DX Compared to Single-Chamber ICDs

THINGS -New Onset AT-AF Diagnosis

 

2-Year Incidence of New-Onset AT/AF Diagnosis

2-Year incidence

Key Result 2

Incidence of OAC Onset: In Tendency Higher with ICD DX

THINGS - Key Result2

2-Year Incidence of OAC Onset After AT/AF Diagnosis

2-Year incidence

Clinical Relevance

  • An early first diagnosis of AT/AF is of clinical importance, yet can be challenging as silent AF is common.
  • DX systems allow early detection of atrial arrhythmias and quantification of arrhythmic burden.
  • The results show that DX systems are associated with an almost 4-fold likelihood of detecting AT/AF compared to conventional devices.
  • The diagnosis of AT/AF often leads to clinical interventions, mainly represented by oral anticoagulation (OAC) onset.

 

Study Details

Study Objective

  • To explore whether a single-lead ICD with an atrial dipole (ICD DX) improves AT/AF diagnosis and management compared to standard single-chamber ICD (ICD VR)

Primary Endpoint

  • Incidence of new-onset AT/AF diagnosis and the related clinical interventions

Clinical Sites

  • 15 centers in Italy

Sample Size

  • 376 patients (140 ICD DX and 236 ICD VR)

Main Inclusion Criteria

  • Patients with standard ICD indication for ischemic or non-ischemic cardiomyopathy according to the last ESC Guidelines

Main Exclusion Criteria

  • Patients needing atrial pacing

Follow-Up

  • In-hospital study follow-ups were performed every 6 months for a period longer than 2 years

Study Duration

  • July 2007 - December 2010

Principal Investigators

  • Mauro Biffi (Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Maplighi, Bologna, Italy.)

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