Atrial Fibrillation (AF), Cryptogenic Stroke, Syncope, Tachyarrhythmia
Conditions
Brief summary
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.
Interventions
DEVICEBIOMONITOR III and BIOMONITOR IIIm
* Insertion of BIOMONITOR III or BIOMONITOR IIIm * three scheduled in-office follow-ups * 48-hour Holter ECG
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patient is at high risk of developing a clinically important cardiac arrhythmia; or * Patient is undergoing investigation for symptoms such as palpitations, pre- syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or * Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or * Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure. * Patient is able to understand the nature of the study and able to provide written informed consent. * Patient is willing and able to perform all follow-up visits at the investigational site. * Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Exclusion criteria
* Patient is implanted with an ICD or pacemaker. * Patient is pregnant or breast-feeding. * Patient is less than 18 years old. * Patient's life-expectancy is less than 12 months. * Patient is participating in another interventional clinical investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SADE-free Rate Until the 3-month Follow-up | 3 months | SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R-wave Amplitude | 10 days to 4 weeks after insertion; 3-months | The secondary endpoint 1 evaluates the R-wave amplitude at the 1st follow-up and at 3-month follow-up by measuring both, the lowest and the highest amplitude value via the programmer. |
| Noise Burden | 10 days to 4 weeks after insertion; 3-months | The secondary endpoint 2 evaluates the noise burden at the 1st follow-up and at 3-month follow-up by retrieving the percentage of noise via the programmer. |
| Assessment of P-wave Visibility | 10 days to 4 weeks after insertion; 3-months | The secondary endpoint 3 evaluates the P-wave visibility at 1st, 3- and 12-month follow-up. The investigator will evaluate whether P-waves can be recognized in the stored sECGs showing sinus rhythm. The number of heart cycles and observed P-waves which can undoubtly be identified in ECGs will be assessed by the investigator. |
| SADE-free Rate Until the 12-month Follow-up | 12-months | The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion. |
Countries
Australia, Austria, Denmark, Germany, Spain, Switzerland
Participant flow
Recruitment details
167 patients completed the informed consent process and signed the informed consent sheet. 166 patients successfully received the investigational device, the BM III.
Pre-assignment details
March 18, 2020: temporary suspension of the enrollment due to the Covid-19 pandemic was announced. All investigators were informed about it and continuation of the follow-up phase. Instructions were given for the safety reporting, deviations from follow-up plan, and reporting of deviation in case these processes are impaired by Covid-19 situation. The suspension was lifted site by site based on pre-specified criteria between June 24, 2020 and February 5, 2021.
Participants by arm
| Arm | Count |
|---|---|
| All Patients BIOMONITOR III and BIOMONITOR IIIm: - Insertion of BIOMONITOR III or BIOMONITOR IIIm
* three scheduled in-office follow-ups
* 48-hour Holter ECG | 167 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Drop-out according to protocol | 34 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Patient unable or unwilling to attend required visits | 8 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Patients | — |
|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 15.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 22 participants | — |
| Region of Enrollment Austria | 23 participants | — |
| Region of Enrollment Denmark | 3 participants | — |
| Region of Enrollment Germany | 97 participants | — |
| Region of Enrollment Spain | 14 participants | — |
| Region of Enrollment Switzerland | 8 participants | — |
| Sex: Female, Male Female | 67 Participants | — |
| Sex: Female, Male Male | 100 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 167 |
| other Total, other adverse events | 59 / 167 |
| serious Total, serious adverse events | 103 / 167 |
Outcome results
Primary
SADE-free Rate Until the 3-month Follow-up
SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up
Time frame: 3 months
Population: All patients who either had a primary endpoint or who had reached 3 months of follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Patients | SADE-free Rate Until the 3-month Follow-up | 141 Participants |
Comparison: The primary hypothesis evaluates the SADE free rate (pSADE\_free) at 3 months. Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%p-value: 0.0595% CI: [0.9, 1]t-test, 2 sided
Secondary
Assessment of P-wave Visibility
The secondary endpoint 3 evaluates the P-wave visibility at 1st, 3- and 12-month follow-up. The investigator will evaluate whether P-waves can be recognized in the stored sECGs showing sinus rhythm. The number of heart cycles and observed P-waves which can undoubtly be identified in ECGs will be assessed by the investigator.
Time frame: 10 days to 4 weeks after insertion; 3-months
Secondary
Noise Burden
The secondary endpoint 2 evaluates the noise burden at the 1st follow-up and at 3-month follow-up by retrieving the percentage of noise via the programmer.
Time frame: 10 days to 4 weeks after insertion; 3-months
Secondary
R-wave Amplitude
The secondary endpoint 1 evaluates the R-wave amplitude at the 1st follow-up and at 3-month follow-up by measuring both, the lowest and the highest amplitude value via the programmer.
Time frame: 10 days to 4 weeks after insertion; 3-months
Secondary
SADE-free Rate Until the 12-month Follow-up
The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.
Time frame: 12-months