Arrhythmias, Cardiac
Conditions
Brief summary
The Reveal LINQ Registry will generate reliable long-term real world data of product performance, economic valuation, site-of-service procedural information.
Detailed description
The study is a prospective, non-randomized, observational, multi-center, global study. The study will characterize clinical actions initiated by Reveal LINQ arrhythmia detection and estimate procedure-related acute infection rate. Approximately 1,500 subjects will be implanted with a Reveal LINQ ICM and undergo continuous remote monitoring and be followed prospectively from insertion through 36 months.
Interventions
DEVICEReveal LINQ
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements. * Subject is intended to receive or be treated with the have a Reveal LINQ ICM inserted in the next 30 days. * Patient enrolled before or on the same date of insertion of the Reveal LINQ ICM * Subject consent prior to ICM insertion
Exclusion criteria
* Subject who is, or is expected to be inaccessible for follow-up * Subject with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | Implant to 36 months post-implant | Clinical actions taken over the course of study follow-up |
| Number of Participants With Procedure-related Acute Infection Rate | Implant to 30 days post-implant | Acute infection rate in the subjects who were followed for at least 30 days or had an infection prior to 30 days. Infections are as assessed by the Investigator and defined as deep incision site or superficial infection. Deep incision site are classified as pain, redness, or drainage at incision site requiring the device to be removed or IV antibiotics administered. Superficial infections are defined as redness beyond procedure expectation and oral antibiotics administered. For both deep incision and superficial infections, a physician directed intervention must occur for the event to be defined as an infection. |
Countries
Belgium, Greece, Israel, Italy, Japan, Netherlands, Portugal, Saudi Arabia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LINQ Subjects Subjects who were confirmed to have been implanted with a LINQ device | 1,604 |
| Total | 1,604 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 43 |
| Overall Study | Exited before 36 months | 1,119 |
Baseline characteristics
| Characteristic | LINQ Subjects |
|---|---|
| Age, Categorical <=18 years | 28 Participants |
| Age, Categorical >=65 years | 806 Participants |
| Age, Categorical Between 18 and 65 years | 770 Participants |
| Age, Continuous | 61.7 years STANDARD_DEVIATION 16.8 |
| NYHA Class I | 27 Participants |
| NYHA Class II | 27 Participants |
| NYHA Class III | 9 Participants |
| NYHA Not Available | 195 Participants |
| NYHA Patient does not have Heart Failure | 1346 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 233 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 435 Participants |
| Race (NIH/OMB) White | 877 Participants |
| Reason for Implant AF Management | 177 Participants |
| Reason for Implant Cryptogenic Stroke | 291 Participants |
| Reason for Implant Other | 76 Participants |
| Reason for Implant Palpitations | 177 Participants |
| Reason for Implant Post-AF Ablation Monitoring | 78 Participants |
| Reason for Implant Pre-AF Ablation Monitoring | 27 Participants |
| Reason for Implant Seizures | 2 Participants |
| Reason for Implant Suspected AF | 178 Participants |
| Reason for Implant Syncope | 540 Participants |
| Reason for Implant Transient Ischemic Attack (TIA) | 9 Participants |
| Reason for Implant Ventricular Tachycardia | 49 Participants |
| Region of Enrollment Belgium | 35 participants |
| Region of Enrollment Germany | 27 participants |
| Region of Enrollment Greece | 32 participants |
| Region of Enrollment Israel | 8 participants |
| Region of Enrollment Italy | 166 participants |
| Region of Enrollment Japan | 215 participants |
| Region of Enrollment Netherlands | 41 participants |
| Region of Enrollment Portugal | 101 participants |
| Region of Enrollment Saudi Arabia | 42 participants |
| Region of Enrollment Spain | 11 participants |
| Region of Enrollment United Kingdom | 6 participants |
| Region of Enrollment United States | 920 participants |
| Sex: Female, Male Female | 682 Participants |
| Sex: Female, Male Male | 922 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 43 / 1,604 |
| other Total, other adverse events | 0 / 1,604 |
| serious Total, serious adverse events | 64 / 1,604 |
Outcome results
Primary
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature
Clinical actions taken over the course of study follow-up
Time frame: Implant to 36 months post-implant
Population: Subjects who had an opportunity to have an action taken after ICM insertion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Registry | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | Stopped OAC medication at least once during study (was on at baseline) | 141 Number of times action taken |
| Registry | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | Started OAC medication at least once during study (was off at baseline) | 176 Number of times action taken |
| Registry | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | AF Ablation | 201 Number of times action taken |
| Registry | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | Electrical Cardioversion | 75 Number of times action taken |
| Registry | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | Other Ablation | 32 Number of times action taken |
| Registry | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | PCI | 9 Number of times action taken |
| Registry | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | PFO Closure | 4 Number of times action taken |
| Registry | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | Therapeutic Device Implanted | 176 Number of times action taken |
| Registry | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | Aortic valve replacement | 1 Number of times action taken |
| Registry | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | Placement of a Watchman device | 1 Number of times action taken |
Primary
Number of Participants With Procedure-related Acute Infection Rate
Acute infection rate in the subjects who were followed for at least 30 days or had an infection prior to 30 days. Infections are as assessed by the Investigator and defined as deep incision site or superficial infection. Deep incision site are classified as pain, redness, or drainage at incision site requiring the device to be removed or IV antibiotics administered. Superficial infections are defined as redness beyond procedure expectation and oral antibiotics administered. For both deep incision and superficial infections, a physician directed intervention must occur for the event to be defined as an infection.
Time frame: Implant to 30 days post-implant
Population: Same as arm/group description
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Registry | Number of Participants With Procedure-related Acute Infection Rate | 8 Participants |