Confirm Rx™ Versus Reveal LINQ™ - Which is More Reliable in Data Transmission? A Randomized Clinical Study
1 other identifier
interventional
209
1 country
2
Brief Summary
This study will compare the reliability and timeliness in data transmission of the Abbott Confirm Rx™ loop recorder with the Medtronic Reveal LINQ™ loop recorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 18, 2018
CompletedFirst Submitted
Initial submission to the registry
October 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2020
CompletedMarch 10, 2020
March 1, 2020
1.8 years
October 24, 2018
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time from arrhythmic events to time of physician notification
12 months
Time from activated events to time of physician notification
12 months
Secondary Outcomes (1)
Time from arrhythmic events to time of intervention if any
12 months
Study Arms (2)
Abbott, Inc Confirm Rx™
ACTIVE COMPARATOREvery other consenting subject will receive the Abbott Inc. Confirm Rx™ device.
Medtronic, Inc Reveal LINQTM
ACTIVE COMPARATOREvery other consenting subject will receive the Medtronic, Inc. Reveal LINQTM.
Interventions
Comparing reliability and timeliness in data transmission between two implantable cardiac monitors.
Eligibility Criteria
You may qualify if:
- Patient is 18 years of age or older
- Patient is willing and able to provide written informed consent
- Patient is willing and able to comply with the protocol, including follow-up visits and MyCareLink™ and Merlin™ transmissions (standard of care)
- Candidates for implantable cardiac monitor
You may not qualify if:
- Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a study manager
- Patient has existing IPG, ICD, CRT-D or CRT-P device
- Adequate sensing in one week post implant. If sensing not adequate, patient will be in the registry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sparrow Clinical Research Institutelead
- Abbottcollaborator
Study Sites (2)
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John H Ip, MD
Sparrow Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
October 24, 2018
First Posted
October 25, 2018
Study Start
May 18, 2018
Primary Completion
March 9, 2020
Study Completion
March 9, 2020
Last Updated
March 10, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share