Trial Outcomes & Findings for DEtermining Accuracy and TrEnding CharacTerization of AF (NCT NCT01673256)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

90 participants

Primary outcome timeframe

4 days after Holter starts

Results posted on

2019-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	SJM Confirm ICM Observational Group SJM Confirm ICM
Overall Study STARTED	90
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DEtermining Accuracy and TrEnding CharacTerization of AF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SJM Confirm ICM Observational Group n=90 Participants SJM Confirm ICM
Age, Continuous	65.7 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants
Region of Enrollment Netherlands	5 participants n=5 Participants
Region of Enrollment Germany	85 participants n=5 Participants
Weight	82.4 kg STANDARD_DEVIATION 16.4 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SJM Confirm ICM Observational Group n=79 Participants SJM Confirm ICM
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 Interval 71.6 to 96.1
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 Interval 91.9 to 100.0

Adverse Events

SJM Confirm ICM Observational Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kyle Brunner

St. Jude Medical Inc.

Phone: 651.756.3482

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60