Atrial Fibrillation
Conditions
Brief summary
The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).
Interventions
DEVICESJM Confirm ICM
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject has been implanted with a SJM Confirm ICM, DM2102. * The subject has or is suspected to have paroxysmal AF. * The subject is ≥ 18 years of age. * The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).
Exclusion criteria
* The subject has persistent (\>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF \>1 year) or permanent AF (not attempting to restore sinus rhythm). * The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease). * The subject has a contraindication to Holter recording. * The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102. * The subject is unable to comply with the follow up schedule. * The subject is participating in another investigational device or drug investigation. * The subject is pregnant or is planning to become pregnant during the duration of the investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording. | 4 days after Holter starts | Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM. Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor. |
Countries
Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SJM Confirm ICM Observational Group SJM Confirm ICM | 90 |
| Total | 90 |
Baseline characteristics
| Characteristic | SJM Confirm ICM Observational Group |
|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment Germany | 85 participants |
| Region of Enrollment Netherlands | 5 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 55 Participants |
| Weight | 82.4 kg STANDARD_DEVIATION 16.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 |
Outcome results
Primary
Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.
Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM. Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor.
Time frame: 4 days after Holter starts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SJM Confirm ICM Observational Group | Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording. | Duration Sensitivity | 83.9 percentage |
| SJM Confirm ICM Observational Group | Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording. | Duration Positive Predictive Value | 97.3 percentage |