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

February 1, 2019 updated by: Abbott Medical Devices

OptiSense Performance in Detecting Atrial Episodes in CRMD Device Patient Population

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44304
        • Northeast Ohio Cardiovascular Specialists
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with approved pacemaker indications.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD459

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Tendril Lead

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe