Reveal LINQ Usability Study

Completed

Conditions: arrhythmia
Syncope
10007521

Registration Number: NL-OMON38774

Lead Sponsor: Medtronic Trading NL BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Subject is indicated for a Reveal device
o Phase I (initial 30 subjects): Any indication for a Reveal LINQ Device
o Phase II (after the initial 30 subjects): Subject has atrial fibrillation and is
indicated for and identified as an AF pre-ablation candidate

Exclusion Criteria

* Subject has an active implanted cardiac medical device (e.g., IPG, ICD, CRT).
* Subject is unwilling or unable to comply with the study procedures

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>See protocol page 24<br /><br><br /><br>The primary objective is to evaluate the Reveal LINQ system functionality.<br /><br>Specifically:<br /><br>* Assess the percentage of successful wireless transmissions<br /><br>* Characterize sensing performance<br /><br>o Signal amplitude and quality of R-wave amplitude at implant and 1<br /><br>month</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>See protocol page 24<br /><br><br /><br>The secondary objectives are to evaluate the Reveal LINQ device specificity for<br /><br>arrhythmia detection and to assess the safety and efficacy of the Reveal LINQ<br /><br>system. The following will be assessed through 1 month post-insertion in Phase<br /><br>I subjects, with subsequent analyses performed at 12 months post-implant in all<br /><br>subjects:<br /><br><br /><br>- Report the System Related Adverse Events<br /><br>- Report the Procedure Related Adverse Events<br /><br>- Comparison of sensing/detection accuracy compared to Holter monitoring for AF<br /><br>- Assessment of AF detection<br /><br>- Evaluate physician satisfaction with the insertion procedure and insertion<br /><br>tools<br /><br>- Evaluate physician satisfaction of data access and ease of use<br /><br>- Evaluate patient satisfaction Physician/Patient Survey<br /><br>- Evaluate physician satisfaction with the explant procedure and any adverse<br /><br>events</p><br>