Insertable Cardiac Monitor
Conditions
Brief summary
The purpose of this study is to evaluate the safety and feasibility of performing the BioMonitor 2 insertion procedure in an office setting.
Interventions
DEVICEBioMonitor 2 Insertable Cardiac Monitor
Sponsors
Biotronik, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indicated for continuous monitoring with an insertable cardiac monitor * Willing to be implanted in an office setting with only local anesthetic available * Able to understand the nature of the study and provide informed consent * Able and willing to complete all routine follow-up visits at the study site for the expected 90-day follow-up * Able and willing to use a CardioMessenger® capable of communicating with the BioMonitor 2 * Age greater than or equal to 18 years At the time of insertion, the following pre-procedure criteria must be met for the subject to undergo insertion: * Most recent INR value (within 7 days) is less than 3.5 if currently taking warfarin * Absence of infection with no history of infection within the last 30 days
Exclusion criteria
* Compromised immune system or at high risk of developing an infection * Abnormal thoracic anatomy or scar tissue at the implant site that may adversely impact the insertion procedure * Enrolled in any investigational cardiac device trial * Currently indicated for or implanted with a pacemaker, ICD device, or hemodynamic monitoring system * Currently implanted with an ICM or ILR * Life expectancy less than 6 months * Patients reporting pregnancy at the time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve | Insertion through 90 days | In order to be included in the primary objective analysis, insertion procedure-related adverse events must also include resolution by invasive action such as device removal, device replacement, surgical repositioning of the device, or another surgery preformed related to the device or primary insertion procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective | Insertion through 90 days | All insertion procedure-related adverse events not included in the Primary Objective |
| Characterization of Insertion Procedure: Device Orientation | At insertion | Position A includes orientations at 45 degrees relative to the sternum over the fourth intercostal space, position B includes orientations parallel to the sternum over the fourth intercostal space, and position C includes orientations perpendicular to the sternum and sub-mammary. |
| Characterization of Insertion Procedure: Incision Size | At insertion | — |
| Characterization of Insertion Procedure: Procedure Duration | At insertion | — |
| Characterization of Device Functionality Post-insertion: R-wave Amplitudes | Insertion, Wound Check (5 to 14 days post-insertion), 90-day (75 to 120 days post-insertion) | This includes average R-wave amplitudes collected at insertion, wound check, and 90-day study visits. Long-term trends available through Home Monitoring from insertion through the 90-day study period was also collected and presented as a separate average. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BioMonitor 2 In-Office Setting Insertion Group Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor. | 77 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device Replaced with Pacemaker | 4 |
| Overall Study | Withdrawn by Investigator | 1 |
Baseline characteristics
| Characteristic | BioMonitor 2 In-Office Setting Insertion Group |
|---|---|
| Age, Customized Age at Enrollment | 62.1 years STANDARD_DEVIATION 15.38 |
| Height | 67.8 inches STANDARD_DEVIATION 4.82 |
| Race/Ethnicity, Customized Black or African American | 5 Participants |
| Race/Ethnicity, Customized Ethnicity Not Specified | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino Ethnicity | 76 Participants |
| Race/Ethnicity, Customized Race Not Specified | 1 Participants |
| Race/Ethnicity, Customized White | 71 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 41 Participants |
| Weight | 205.6 pounds STANDARD_DEVIATION 47.93 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 77 |
| other Total, other adverse events | 2 / 77 |
| serious Total, serious adverse events | 0 / 77 |
Outcome results
Primary
Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve
In order to be included in the primary objective analysis, insertion procedure-related adverse events must also include resolution by invasive action such as device removal, device replacement, surgical repositioning of the device, or another surgery preformed related to the device or primary insertion procedure.
Time frame: Insertion through 90 days
Population: The evaluable subject population is the sum of total unique subjects who completed the 90-day follow-up and/or who experienced a primary objective adverse event.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BioMonitor 2 In-Office Setting Insertion Group | Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve | 0 participants with a Primary Objective AE |
Secondary
Characterization of Device Functionality Post-insertion: R-wave Amplitudes
This includes average R-wave amplitudes collected at insertion, wound check, and 90-day study visits. Long-term trends available through Home Monitoring from insertion through the 90-day study period was also collected and presented as a separate average.
Time frame: Insertion, Wound Check (5 to 14 days post-insertion), 90-day (75 to 120 days post-insertion)
Population: Five subjects did not complete their 90-day visits as reported in Participant Flow and therefore data was not collected for those visits. Only one subject did not transmit to Home Monitoring due to poor reception and therefore there was no data for this patient in Home Monitoring.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BioMonitor 2 In-Office Setting Insertion Group | Characterization of Device Functionality Post-insertion: R-wave Amplitudes | Insertion Procedure Visit | 0.77 millivolts (mV) | Standard Deviation 0.5 |
| BioMonitor 2 In-Office Setting Insertion Group | Characterization of Device Functionality Post-insertion: R-wave Amplitudes | Wound Check Visit | 0.69 millivolts (mV) | Standard Deviation 0.4 |
| BioMonitor 2 In-Office Setting Insertion Group | Characterization of Device Functionality Post-insertion: R-wave Amplitudes | 90-day Follow-up Visit | 0.67 millivolts (mV) | Standard Deviation 0.3 |
| BioMonitor 2 In-Office Setting Insertion Group | Characterization of Device Functionality Post-insertion: R-wave Amplitudes | Home Monitoring 90-day Average | 0.68 millivolts (mV) | Standard Deviation 0.34 |
Secondary
Characterization of Insertion Procedure: Device Orientation
Position A includes orientations at 45 degrees relative to the sternum over the fourth intercostal space, position B includes orientations parallel to the sternum over the fourth intercostal space, and position C includes orientations perpendicular to the sternum and sub-mammary.
Time frame: At insertion
Population: All subjects who underwent insertion
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BioMonitor 2 In-Office Setting Insertion Group | Characterization of Insertion Procedure: Device Orientation | Position A | 35 Participants |
| BioMonitor 2 In-Office Setting Insertion Group | Characterization of Insertion Procedure: Device Orientation | Position B | 38 Participants |
| BioMonitor 2 In-Office Setting Insertion Group | Characterization of Insertion Procedure: Device Orientation | Position C | 1 Participants |
| BioMonitor 2 In-Office Setting Insertion Group | Characterization of Insertion Procedure: Device Orientation | Other | 3 Participants |
Secondary
Characterization of Insertion Procedure: Incision Size
Time frame: At insertion
Population: Number of participants analyzed included all subjects with a reported incision size. Incision size was not collected or reported for 3 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioMonitor 2 In-Office Setting Insertion Group | Characterization of Insertion Procedure: Incision Size | 14.9 millimeters | Standard Deviation 3.74 |
Secondary
Characterization of Insertion Procedure: Procedure Duration
Time frame: At insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BioMonitor 2 In-Office Setting Insertion Group | Characterization of Insertion Procedure: Procedure Duration | 8.4 minutes | Standard Deviation 3.69 |
Secondary
Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective
All insertion procedure-related adverse events not included in the Primary Objective
Time frame: Insertion through 90 days
Population: The evaluable subject population is the sum of total unique subjects who completed the 90-day follow-up and/or who experienced a secondary objective adverse event.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BioMonitor 2 In-Office Setting Insertion Group | Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective | 2 Participants |