OptiSense™ Performance in Detecting Atrial Episodes (SENSE-AF)

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Abbott

Status

Completed

Conditions

Atrial Fibrillation
Tachyarrhythmias

Treatments

Device: OptiSense Lead
Device: Tendril Lead

Study type

Observational

Funder types

Industry

Identifiers

NCT00870324
CRD459

Details and patient eligibility

About

The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW). The performance of the lead will be measured as a difference in device-determined time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to the control group which will be randomized to receive SJM's Tendril™ RA leads.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who meets current ICD or CRT-D implant indications and receive a St. Jude Medical ICD/CRT-D
  • Patients who will receive a new St. Jude Medical OptiSense or Tendril RA lead as part of their device implant

Exclusion criteria

  • Patients with a history of Permanent or Persistent AF
  • Patient's life expectancy is less than 12 months.
  • Patient is pregnant.
  • Patient's age at enrollment is less than 18 years.

Trial design

50 participants in 2 patient groups

1. Control
Description:
Patients will receive the Tendril (wide-spaced) lead as part of their ICD implant
Treatment:
Device: Tendril Lead
2. Experimental
Description:
Patients will receive the OptiSense (narrow-spaced) lead as part of their ICD implant
Treatment:
Device: OptiSense Lead

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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