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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00870324
First received: March 25, 2009
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Tachyarrhythmias
Atrial Fibrillation
Device: OptiSense Lead
Device: Tendril Lead
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration). [ Time Frame: 3 months post-implant ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Control
Patients will receive the Tendril (wide-spaced) lead as part of their ICD implant
Device: Tendril Lead
The Tendril® is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in either the atrium or the ventricle. The tip-to-ring spacing in the Tendril is "wide spaced" compared to the OptiSense lead.
Experimental: 2. Experimental
Patients will receive the OptiSense (narrow-spaced) lead as part of their ICD implant
Device: OptiSense Lead
The OptiSense™ Model 1699 lead is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in the right atrium. The tip-to-ring spacing in the OptiSense lead is 1.1mm and "narrow-spaced" compared to the Tendril lead.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870324

Locations
United States, Ohio
Northeast Ohio Cardiovascular Specialists
Akron, Ohio, United States, 44304
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00870324     History of Changes
Other Study ID Numbers: CRD459
Study First Received: March 25, 2009
Last Updated: August 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Medical:
ICD
Tachyarrhythmias
Atrial Fibrillation
Patients who meets current ICD or CRT-D implant indications

Additional relevant MeSH terms:
Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014