N/A
Completed N=151
Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System
Syncope · Recurrent Symptomatic Atrial Fibrillation
Source: ClinicalTrials.gov NCT01965899 ↗
Enrolled (actual)
151
Serious AEs
20.5%
Results posted
Sep 2016
Primary outcomePrimary: Success of Wireless Transmissions — 73.1 percentage of successful transmissions
Summary
The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success of Wireless Transmissions |
73.1 | — |
| PRIMARY R-wave Amplitude |
543.5; 599.4 | — |
| PRIMARY R-wave Amplitudes Greater Than or Equal to 200 μV |
97.3; 96.6 | — |
| SECONDARY Accuracy of Reveal LINQ Device Detected Atrial Fibrillation |
4461; 843 | — |
| SECONDARY Safety Endpoint |
9; 45; 1; 1 | — |
| SECONDARY Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor |
97.4; 97.0; 92.5; 99.0; 97.1 | — |
| SECONDARY Survey of the Implanting Physicians |
54.4; 38.9; 5.4; 1.3 | — |
| SECONDARY Survey of the Patient Experience Over Time |
66.6; 30.2; 2.8; 0.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is willing to sign and date the consent form.
- Subject is indicated for a Reveal device within the existing market approved indications
- Phase I (initial 30 subjects): Any indication for a Reveal LINQ Device
- Phase II (after the initial 30 subjects): Subject has atrial fibrillation and is indicated for and identified as an AF pre-ablation candidate*
*Note: Atrial fibrillation must be documented in the subject's medical history.
- Subject has a life expectancy of 18 months or more.
- Subject is willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored (i.e., Medtronic CareLink® Network)
- Subjects who are female of childbearing potential (last menses less than 1 year prior to enrolment) must:
- have a negative pregnancy test at enrollment.
- not be breastfeeding.
- either be surgically sterile, postmenopausal (cessation of menses for at least 1 year), or agree to use a medically accepted, highly effective method of contraception during the entire duration of the study.
Exclusion Criteria
- Subject has an active implanted cardiac medical device (e.g., IPG, ICD, CRT, etc).
- Subject is unwilling or unable to comply with the study procedures
- Subject is legally incapacitated and unable to provide written informed consent.
- Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological diagnosis)
- Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager.
- Local law prohibits participation (e.g., minor status as specified by local law)
Data sourced from ClinicalTrials.gov (NCT01965899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.