Trial Outcomes & Findings for Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation (NCT NCT04190186)
NCT ID: NCT04190186
Last Updated: 2025-07-29
Results Overview
In the present study AF burden will be assessed at 3-month intervals during the 12 months following the blanking period (3-months post-ablation), and the difference at the end of the follow-up period of one year will serve as the primary comparison outcome between the two treatment groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
Results posted on
2025-07-29
Participant Flow
Participant milestones
| Measure |
Biotronik ICM-guided AF Management
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Biotronik ICM-guided AF Management
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Overall Study
ILR is no longer functioning
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Subject choice to explant
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Study was stopped
|
4
|
5
|
Baseline Characteristics
Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
65.7 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
64.6 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)In the present study AF burden will be assessed at 3-month intervals during the 12 months following the blanking period (3-months post-ablation), and the difference at the end of the follow-up period of one year will serve as the primary comparison outcome between the two treatment groups.
Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Atrial Fibrillation (AF) Burden Defined as the Mean Amount of Time Spent in AF Over a Pre-specified Period of Time (Excluding Short AF Episodes of ≤30 Seconds) by the Biotronik ICM (BioMonitor3® or Future Generation of Biotronik ICM).
|
4.99 percentage of time spent in AF
Standard Deviation 8.26
|
2.57 percentage of time spent in AF
Standard Deviation 4.41
|
SECONDARY outcome
Timeframe: Between enrollment and 15 months (excluding the initial 3-month blanking period) (assessed in a recurrent event analysis).Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Number of Participants With Clinically Significant (>30 Min) Atrial Arrhythmia (Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) as Detected and Documented by Biotronik ICM After the Performance of the Index AF Ablation Procedure.
|
0.0 Participants
|
0.0 Participants
|
SECONDARY outcome
Timeframe: Between enrollment and 15 months.Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Number of Participants With Symptomatic AF Recurrence (Regardless of Duration).
|
0.0 Participants
|
0.0 Participants
|
SECONDARY outcome
Timeframe: Between enrollment and 15 months.Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Number of Participants With Repeat AF Ablation.
|
3.0 Participants
|
4.0 Participants
|
SECONDARY outcome
Timeframe: Between enrollment and 15 months.Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Number of Participants With Cardiac Hospitalization.
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Between enrollment and 15 months.Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Number of Deaths.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Between enrollment and 15 months.Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Number of Participants With Healthcare Utilization, Defined as Hospitalization for Any Cause, ED Visits, and Unplanned Office Visits.
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)Incidence of atrial flutter or tachycardia after the index ablation procedure
Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Number of Participants With Atrial Flutter or Tachycardia.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Number of Participants With Incidence of Repeat Procedures.
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Number of Participants With Major Adverse Events Requiring Rehospitalization During Follow-up.
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)The Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire is a validated, disease-specific instrument used to assess quality of life in individuals with atrial fibrillation. It includes 20 questions across four domains: Symptoms, Daily Activities, Treatment Concern, and Treatment Satisfaction. The AFEQT provides both domain-specific scores and an overall total score. Scores for each domain and the Total Score range from 0 to 100. Higher scores indicate better quality of life, with 100 representing no symptoms or limitations and 0 representing severe symptoms or limitations. The Total Score is calculated by averaging the scores from the three core domains (Symptoms, daily activities, and treatment concern).
Outcome measures
| Measure |
Biotronik ICM-guided AF Management
n=27 Participants
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 Participants
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Quality of Life as Assessed by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire
|
88.0 Score (from the AFEQT questionnaire)
Standard Deviation 14.6
|
85.9 Score (from the AFEQT questionnaire)
Standard Deviation 12.6
|
Adverse Events
Biotronik ICM-guided AF Management
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Conventional AF Management
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Biotronik ICM-guided AF Management
n=27 participants at risk
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 participants at risk
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
1/27 • 15 months
|
0.00%
0/28 • 15 months
|
|
Cardiac disorders
Atrial Arrhythmia
|
0.00%
0/27 • 15 months
|
3.6%
1/28 • 15 months
|
|
Cardiac disorders
Congestive Heart Failure
|
3.7%
1/27 • 15 months
|
0.00%
0/28 • 15 months
|
|
General disorders
Generalized Weakness
|
0.00%
0/27 • 15 months
|
7.1%
2/28 • 15 months
|
|
General disorders
Pain (General)
|
3.7%
1/27 • 15 months
|
0.00%
0/28 • 15 months
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/27 • 15 months
|
3.6%
1/28 • 15 months
|
Other adverse events
| Measure |
Biotronik ICM-guided AF Management
n=27 participants at risk
ICM obtained data will be actively used to guide and monitor treatment .
Insertable Cardiac Monitor: Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
|
Conventional AF Management
n=28 participants at risk
Treating physicians/nurses will be blinded to the AF episodes data from the monitor, but will be provided information on asystole, or ventricular arrhythmia events (for safety).
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
7.4%
2/27 • 15 months
|
3.6%
1/28 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough Increased
|
0.00%
0/27 • 15 months
|
3.6%
1/28 • 15 months
|
|
Eye disorders
Diplopia
|
0.00%
0/27 • 15 months
|
3.6%
1/28 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
1/27 • 15 months
|
0.00%
0/28 • 15 months
|
|
General disorders
Fever
|
0.00%
0/27 • 15 months
|
3.6%
1/28 • 15 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
1/27 • 15 months
|
0.00%
0/28 • 15 months
|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
1/27 • 15 months
|
0.00%
0/28 • 15 months
|
|
Cardiac disorders
Atrial Arrhythmia
|
0.00%
0/27 • 15 months
|
7.1%
2/28 • 15 months
|
|
Cardiac disorders
Congestive Heart Failure
|
3.7%
1/27 • 15 months
|
0.00%
0/28 • 15 months
|
|
General disorders
Generalized Weakness
|
0.00%
0/27 • 15 months
|
7.1%
2/28 • 15 months
|
|
General disorders
Pain (General)
|
11.1%
3/27 • 15 months
|
3.6%
1/28 • 15 months
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/27 • 15 months
|
3.6%
1/28 • 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place