OptiSense™ Performance in Detecting Atrial Episodes

NCT00870324 | Completed DMC

• 1 other identifier: CRD459
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tachyarrhythmias; Atrial Fibrillation

Keywords

ICD; Tachyarrhythmias; Atrial Fibrillation; Patients who meets current ICD or CRT-D implant indications

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months post-implant

Study Arms (2)

1. Control

Patients will receive the Tendril (wide-spaced) lead as part of their ICD implant

Device: Tendril Lead

2. Experimental

Patients will receive the OptiSense (narrow-spaced) lead as part of their ICD implant

Device: OptiSense Lead

Interventions

OptiSense Lead DEVICE

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.

2. Experimental

Tendril Lead DEVICE

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.

1. Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with approved pacemaker indications.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (2)

Northeast Ohio Cardiovascular Specialists

Akron, Ohio, 44304, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Tachycardia; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 27, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

US (2)