Persistent Atrial Fibrillation
Conditions
Keywords
Biotronik BioMonitor, ICM, AF Ablation, Atrial arrhythmia
Brief summary
This clinical trial is designed to compare two management strategies for the treatment of asymptomatic/subclinical atrial fibrillation after ablation based on data from the Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).
Detailed description
In this study, subjects will be randomized (1:1) to conventional AF management vs. Biotronik ICM-guided AF management following ablation for persistent AF. Subjects will be followed for 15 months including a 3 month blanking period following AF ablation. The study subject population will include subjects with persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than 1 year), according to current guideline indications for persistent AF ablation and ICM (Biotronik ICM) implantation.
Interventions
Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
Sponsors
Biotronik, Inc.
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * History of persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than a year) * Planned to undergo first AF ablation with successful Biotronik ICM implant before or at time of ablation
Exclusion criteria
* Paroxysmal atrial fibrillation * Long persistent atrial fibrillation (continuous atrial fibrillation that lasts more than 1 year) * Permanent atrial fibrillation * Left atrial diameter of 60 mm or greater * Patients with CHF status prohibiting EP study and ablation, but may be re-considered for enrollment later after effective treatment * Patients with metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting EP study and ablation or antiarrhythmic medical therapy (e.g. dofetilide, sotalol or amiodarone, etc.) * Patients with an intra-cardiac thrombus, but may be re-considered for enrollment later after effective treatment * Serious known concomitant disease with a life expectancy of \< 1 year * Pregnancy or nursing * Unwilling or unable to give informed consent * Existing CIED such as pacemaker or ICD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Symptomatic AF Recurrence (Regardless of Duration). | Between enrollment and 15 months. | — |
| Number of Participants With Repeat AF Ablation. | Between enrollment and 15 months. | — |
| Number of Participants With Cardiac Hospitalization. | Between enrollment and 15 months. | — |
| Number of Deaths. | Between enrollment and 15 months. | — |
| 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. | Between enrollment and 15 months (excluding the initial 3-month blanking period) (assessed in a recurrent event analysis). | — |
| Number of Participants With Atrial Flutter or Tachycardia. | 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 |
| Number of Participants With Incidence of Repeat Procedures. | Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) | — |
| Number of Participants With Major Adverse Events Requiring Rehospitalization During Follow-up. | Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period) | — |
| Quality of Life as Assessed by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire | 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). |
| Number of Participants With Healthcare Utilization, Defined as Hospitalization for Any Cause, ED Visits, and Unplanned Office Visits. | Between enrollment and 15 months. | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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). | 28 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | ILR is no longer functioning | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Study was stopped | 4 | 5 |
| Overall Study | Subject choice to explant | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Conventional AF Management | Total | Biotronik ICM-guided AF Management |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 18 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 37 Participants | 16 Participants |
| Age, Continuous | 63.5 Years STANDARD_DEVIATION 9.3 | 64.6 Years STANDARD_DEVIATION 8.8 | 65.7 Years STANDARD_DEVIATION 8.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 55 Participants | 27 Participants |
| Region of Enrollment United States | 28 participants | 55 participants | 27 participants |
| Sex: Female, Male Female | 6 Participants | 16 Participants | 10 Participants |
| Sex: Female, Male Male | 22 Participants | 39 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 28 |
| other Total, other adverse events | 8 / 27 | 9 / 28 |
| serious Total, serious adverse events | 3 / 27 | 3 / 28 |
Outcome results
Primary
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).
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.
Time frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biotronik ICM-guided AF Management | 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 |
| Conventional AF Management | 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). | 2.57 percentage of time spent in AF | Standard Deviation 4.41 |
p-value: 0.594Wilcoxon (Mann-Whitney)
Secondary
Number of Deaths.
Time frame: Between enrollment and 15 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biotronik ICM-guided AF Management | Number of Deaths. | 0 Participants |
| Conventional AF Management | Number of Deaths. | 0 Participants |
Secondary
Number of Participants With Atrial Flutter or Tachycardia.
Incidence of atrial flutter or tachycardia after the index ablation procedure
Time frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biotronik ICM-guided AF Management | Number of Participants With Atrial Flutter or Tachycardia. | 0 Participants |
| Conventional AF Management | Number of Participants With Atrial Flutter or Tachycardia. | 0 Participants |
Secondary
Number of Participants With Cardiac Hospitalization.
Time frame: Between enrollment and 15 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biotronik ICM-guided AF Management | Number of Participants With Cardiac Hospitalization. | 3 Participants |
| Conventional AF Management | Number of Participants With Cardiac Hospitalization. | 3 Participants |
Secondary
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.
Time frame: Between enrollment and 15 months (excluding the initial 3-month blanking period) (assessed in a recurrent event analysis).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biotronik ICM-guided AF Management | 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 |
| Conventional AF Management | 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 |
Secondary
Number of Participants With Healthcare Utilization, Defined as Hospitalization for Any Cause, ED Visits, and Unplanned Office Visits.
Time frame: Between enrollment and 15 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biotronik ICM-guided AF Management | Number of Participants With Healthcare Utilization, Defined as Hospitalization for Any Cause, ED Visits, and Unplanned Office Visits. | 5 Participants |
| Conventional AF Management | Number of Participants With Healthcare Utilization, Defined as Hospitalization for Any Cause, ED Visits, and Unplanned Office Visits. | 7 Participants |
Secondary
Number of Participants With Incidence of Repeat Procedures.
Time frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biotronik ICM-guided AF Management | Number of Participants With Incidence of Repeat Procedures. | 5 Participants |
| Conventional AF Management | Number of Participants With Incidence of Repeat Procedures. | 4 Participants |
Secondary
Number of Participants With Major Adverse Events Requiring Rehospitalization During Follow-up.
Time frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biotronik ICM-guided AF Management | Number of Participants With Major Adverse Events Requiring Rehospitalization During Follow-up. | 2 Participants |
| Conventional AF Management | Number of Participants With Major Adverse Events Requiring Rehospitalization During Follow-up. | 3 Participants |
Secondary
Number of Participants With Repeat AF Ablation.
Time frame: Between enrollment and 15 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biotronik ICM-guided AF Management | Number of Participants With Repeat AF Ablation. | 3.0 Participants |
| Conventional AF Management | Number of Participants With Repeat AF Ablation. | 4.0 Participants |
Secondary
Number of Participants With Symptomatic AF Recurrence (Regardless of Duration).
Time frame: Between enrollment and 15 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biotronik ICM-guided AF Management | Number of Participants With Symptomatic AF Recurrence (Regardless of Duration). | 0.0 Participants |
| Conventional AF Management | Number of Participants With Symptomatic AF Recurrence (Regardless of Duration). | 0.0 Participants |
Secondary
Quality of Life as Assessed by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire
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).
Time frame: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Biotronik ICM-guided AF Management | 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 |
| Conventional AF Management | Quality of Life as Assessed by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire | 85.9 Score (from the AFEQT questionnaire) | Standard Deviation 12.6 |