N/A
N=55
Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT04190186 ↗Enrolled (actual)
55
Serious AEs
10.9%
Results posted
Jul 2025
Primary outcome: 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). — 4.99; 2.57 percentage of time spent in AF — p=0.594
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Insertable Cardiac Monitor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
4.99; 2.57 | 0.594 |
| 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. |
0.0; 0.0 | — |
| SECONDARY Number of Participants With Symptomatic AF Recurrence (Regardless of Duration). |
0.0; 0.0 | — |
| SECONDARY Number of Participants With Repeat AF Ablation. |
3.0; 4.0 | — |
| SECONDARY Number of Participants With Cardiac Hospitalization. |
3; 3 | — |
| SECONDARY Number of Deaths. |
0; 0 | — |
| SECONDARY Number of Participants With Healthcare Utilization, Defined as Hospitalization for Any Cause, ED Visits, and Unplanned Office Visits. |
5; 7 | — |
| SECONDARY Number of Participants With Atrial Flutter or Tachycardia. |
0; 0 | — |
| SECONDARY Number of Participants With Incidence of Repeat Procedures. |
5; 4 | — |
| SECONDARY Number of Participants With Major Adverse Events Requiring Rehospitalization During Follow-up. |
2; 3 | — |
| SECONDARY Quality of Life as Assessed by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire |
88.0; 85.9 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04190186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.