Trial Outcomes & Findings for Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study (NCT NCT06352060)
NCT ID: NCT06352060
Last Updated: 2025-04-18
Results Overview
Number of patients with freedom from AF, OAC and AAD Use after 12 months
Recruitment status
COMPLETED
Target enrollment
598 participants
Primary outcome timeframe
12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
Results posted on
2025-04-18
Participant Flow
598 patients, with 299 in the non-ICM and ICM groups, respectively were included in the study.
Participant milestones
| Measure |
Participants With ICM
Patients who underwent ICM insertion
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
Non-ICM Participants
Patients with traditional monitoring methods
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
|---|---|---|
|
Overall Study
STARTED
|
299
|
299
|
|
Overall Study
COMPLETED
|
299
|
299
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study
Baseline characteristics by cohort
| Measure |
Participants With ICM
n=299 Participants
Patients who underwent ICM insertion
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
Non-ICM Participants
n=299 Participants
Patients with traditional monitoring methods
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
Total
n=598 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.3 Years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
72.3 Years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
72.3 Years
STANDARD_DEVIATION 10.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
220 Participants
n=99 Participants
|
242 Participants
n=107 Participants
|
462 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucacian
|
251 Participants
n=99 Participants
|
258 Participants
n=107 Participants
|
509 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
37 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Parosysmal Atrial Fibrillation
|
171 Participants
n=99 Participants
|
234 Participants
n=107 Participants
|
405 Participants
n=206 Participants
|
|
Persistent Atrial Fibrillation
|
128 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
|
Baseline AAD Use
|
120 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Stroke / TIA
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Compensated heart failure (EF <35%)
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Coronary artery disease
|
50 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.Number of patients with freedom from AF, OAC and AAD Use after 12 months
Outcome measures
| Measure |
Participants With ICM
n=299 Participants
Patients who underwent ICM insertion
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
Non-ICM Participants
n=299 Participants
Patients with traditional monitoring methods
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
|---|---|---|
|
Number of Patients With Freedom From AF, OAC and AAD Use
Number of patients with freedom from AAD use
|
230 Participants
|
109 Participants
|
|
Number of Patients With Freedom From AF, OAC and AAD Use
Number of patients with freedom from AF
|
257 Participants
|
185 Participants
|
|
Number of Patients With Freedom From AF, OAC and AAD Use
Number of patients with freedom from OAC use
|
208 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.Clinical Outcomes in Participants With ICM and Non-ICM Participants at 12 months
Outcome measures
| Measure |
Participants With ICM
n=299 Participants
Patients who underwent ICM insertion
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
Non-ICM Participants
n=299 Participants
Patients with traditional monitoring methods
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
|---|---|---|
|
Clinical Outcomes in Participants With ICM and Non-ICM Participants
Access to EP
|
299 Participants
|
180 Participants
|
|
Clinical Outcomes in Participants With ICM and Non-ICM Participants
Attempted Rhythm Control With AAD
|
299 Participants
|
189 Participants
|
|
Clinical Outcomes in Participants With ICM and Non-ICM Participants
OAC Compliance
|
233 Participants
|
216 Participants
|
|
Clinical Outcomes in Participants With ICM and Non-ICM Participants
Initial Ablation
|
275 Participants
|
185 Participants
|
SECONDARY outcome
Timeframe: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.Outcome measures
| Measure |
Participants With ICM
n=299 Participants
Patients who underwent ICM insertion
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
Non-ICM Participants
n=299 Participants
Patients with traditional monitoring methods
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
|---|---|---|
|
Total CV-related Hospital Stay Duration, Days
|
3.5 Days
Standard Deviation 1.9
|
7.4 Days
Standard Deviation 5.3
|
Adverse Events
Participants With ICM
Serious events: 7 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-ICM Participants
Serious events: 24 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With ICM
n=299 participants at risk
Patients who underwent ICM insertion
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
Non-ICM Participants
n=299 participants at risk
Patients with traditional monitoring methods
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
|---|---|---|
|
Cardiac disorders
AF-related hospitalization
|
1.0%
3/299 • 12-Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
All-Cause Mortality events were not monitored/assessed.
|
3.7%
11/299 • 12-Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
All-Cause Mortality events were not monitored/assessed.
|
|
Cardiac disorders
HF-related hospitalization
|
1.3%
4/299 • 12-Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
All-Cause Mortality events were not monitored/assessed.
|
4.3%
13/299 • 12-Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
All-Cause Mortality events were not monitored/assessed.
|
Other adverse events
| Measure |
Participants With ICM
n=299 participants at risk
Patients who underwent ICM insertion
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
Non-ICM Participants
n=299 participants at risk
Patients with traditional monitoring methods
No intervention or administration will be performed due to the observational nature of the study: Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
|
|---|---|---|
|
Cardiac disorders
Stroke/TIA
|
0.33%
1/299 • 12-Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
All-Cause Mortality events were not monitored/assessed.
|
2.3%
7/299 • 12-Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
All-Cause Mortality events were not monitored/assessed.
|
|
Blood and lymphatic system disorders
Major bleeding episodes
|
0.33%
1/299 • 12-Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
All-Cause Mortality events were not monitored/assessed.
|
0.67%
2/299 • 12-Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
All-Cause Mortality events were not monitored/assessed.
|
Additional Information
Dhanunjaya Lakkireddy
Kansas City Heart Rhythm Institute
Phone: 913-934-4300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place