Reveal LINQ Usability Study

Reveal LINQ Usability Study - Reveal LINQ

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38774

Enrollment

Registered

2013-08-28

Start date

2013-09-27

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arrhythmia Syncope

Interventions

The following interventions are additional for all subjects in the

- Short-patient assessment at implantation, 1, 6, and 12 months - 48h Holter at 1 month visit - Xray at implantation and 1 month - Weekly manual CarleLink transmission till 1 month follow-up, and a mo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)