Trial Outcomes & Findings for BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment (NCT NCT02756338)
NCT ID: NCT02756338
Last Updated: 2018-10-26
Results Overview
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.
COMPLETED
77 participants
Insertion through 90 days
2018-10-26
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
77
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawn by Investigator
|
1
|
|
Overall Study
Device Replaced with Pacemaker
|
4
|
Baseline Characteristics
BioMonitor 2 In-Office Setting Insertion Safety and Feasibility Evaluation With Device Functionality Assessment
Baseline characteristics by cohort
| Measure |
BioMonitor 2 In-Office Setting Insertion Group
n=77 Participants
Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
|
|---|---|
|
Age, Customized
Age at Enrollment
|
62.1 years
STANDARD_DEVIATION 15.38 • n=99 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
71 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race Not Specified
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino Ethnicity
|
76 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Not Specified
|
1 Participants
n=99 Participants
|
|
Height
|
67.8 inches
STANDARD_DEVIATION 4.82 • n=99 Participants
|
|
Weight
|
205.6 pounds
STANDARD_DEVIATION 47.93 • n=99 Participants
|
PRIMARY outcome
Timeframe: Insertion through 90 daysPopulation: 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.
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.
Outcome measures
| Measure |
BioMonitor 2 In-Office Setting Insertion Group
n=72 Participants
Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
|
|---|---|
|
Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve
|
0 participants with a Primary Objective AE
|
SECONDARY outcome
Timeframe: Insertion through 90 daysPopulation: 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.
All insertion procedure-related adverse events not included in the Primary Objective
Outcome measures
| Measure |
BioMonitor 2 In-Office Setting Insertion Group
n=73 Participants
Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
|
|---|---|
|
Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective
|
2 Participants
|
SECONDARY outcome
Timeframe: At insertionPopulation: All subjects who underwent 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.
Outcome measures
| Measure |
BioMonitor 2 In-Office Setting Insertion Group
n=77 Participants
Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
|
|---|---|
|
Characterization of Insertion Procedure: Device Orientation
Position A
|
35 Participants
|
|
Characterization of Insertion Procedure: Device Orientation
Position B
|
38 Participants
|
|
Characterization of Insertion Procedure: Device Orientation
Position C
|
1 Participants
|
|
Characterization of Insertion Procedure: Device Orientation
Other
|
3 Participants
|
SECONDARY outcome
Timeframe: At insertionPopulation: Number of participants analyzed included all subjects with a reported incision size. Incision size was not collected or reported for 3 participants.
Outcome measures
| Measure |
BioMonitor 2 In-Office Setting Insertion Group
n=74 Participants
Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
|
|---|---|
|
Characterization of Insertion Procedure: Incision Size
|
14.9 millimeters
Standard Deviation 3.74
|
SECONDARY outcome
Timeframe: At insertionOutcome measures
| Measure |
BioMonitor 2 In-Office Setting Insertion Group
n=77 Participants
Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
|
|---|---|
|
Characterization of Insertion Procedure: Procedure Duration
|
8.4 minutes
Standard Deviation 3.69
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
BioMonitor 2 In-Office Setting Insertion Group
n=77 Participants
Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
|
|---|---|
|
Characterization of Device Functionality Post-insertion: R-wave Amplitudes
Insertion Procedure Visit
|
0.77 millivolts (mV)
Standard Deviation 0.5
|
|
Characterization of Device Functionality Post-insertion: R-wave Amplitudes
Wound Check Visit
|
0.69 millivolts (mV)
Standard Deviation 0.4
|
|
Characterization of Device Functionality Post-insertion: R-wave Amplitudes
90-day Follow-up Visit
|
0.67 millivolts (mV)
Standard Deviation 0.3
|
|
Characterization of Device Functionality Post-insertion: R-wave Amplitudes
Home Monitoring 90-day Average
|
0.68 millivolts (mV)
Standard Deviation 0.34
|
Adverse Events
BioMonitor 2 In-Office Setting Insertion Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BioMonitor 2 In-Office Setting Insertion Group
n=77 participants at risk
Post-market Study: Collecting safety and feasibility of performing office based insertion of a market-released insertable cardiac monitor.
|
|---|---|
|
Surgical and medical procedures
Secondary Infection
|
1.3%
1/77 • Number of events 1 • Insertion through 90 days
|
|
Surgical and medical procedures
Surrounding Tissue Damage
|
1.3%
1/77 • Number of events 1 • Insertion through 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators agree to submit copies of any manuscript proposed for publication to Sponsor for review at least 30 days in advance of submission for publication or presentation. Sponsor may extend such review period another 90 days to file patent applications to take other steps to protect its intellectual property interests, or to remove from the paper or presentation any language that is detrimental to Sponsor's intellectual property interests.
- Publication restrictions are in place
Restriction type: OTHER