Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Fibrillation, Persistent, Heart Diseases
Conditions
Keywords
Electrographic Flow Mapping, Atrial Fibrillation
Brief summary
This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.
Detailed description
The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of Electrographic Flow (EGF™) mapping with Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of EGF mapping to identify sources of atrial fibrillation (AF) and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with AF and meet inclusion/exclusion criteria will be eligible for enrollment.
Interventions
DEVICEElectrographic Flow™ (EGF) mapping and ablation
Electrographic Flow™ (EGF) mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF). EGF mapping involves 1 minute recordings of unipolar electrograms from a basket catheter, which are then processed with the EGF algorithm (Ablamap® Software). Several basket catheter positions are acquired in standard positions in both the left and right atria. EGF-identified sources with activity levels exceeding the recommended threshold are deemed significant and are targeted for ablation. The success of the ablation is confirmed through an EGF remap, where elimination of the source is defined as reduction of EGF source activity below the threshold.
Sponsors
Cortex
Ablacon, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Suitable candidate for intra-cardiac mapping and ablation of arrhythmias. 2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law. 3. Subjects with a history of documented symptomatic atrial fibrillation.
Exclusion criteria
1. Subjects who are not candidates for cardiac ablation procedures. 2. Pregnant or nursing. 3. Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Procedure Success | During the procedure | Acute Procedure Success is defined as targeting and successful elimination of significant sources of electrographic flow (EGF) through radiofrequency ablation. EGF-identified sources are significant when their leading source activity is ≥ 26%. Successful elimination is defined as reduction of the source activity of the leading source to \<26% upon post-ablation remapping using EGF mapping. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 12-month Freedom From AF Recurrence | 90 day - 12 months | This measure represents the number of subjects with freedom from documented episodes of atrial fibrillation (AF) recurrence lasting longer than 30 seconds from the 90-day post-procedure blanking period through 12 months of follow-up. Only subjects with completed 12 month follow-up are included in this analysis. |
Countries
Netherlands, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Electrographic Flow™ Guided Ablation Therapy In addition to standard pulmonary vein isolation (PVI) or PVI touch-up, subjects receive targeted radiofrequency source ablation guided by Electrographic Flow™ (EGF) mapping. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Electrographic Flow™ Guided Ablation Therapy | — |
|---|---|---|
| Age, Continuous | 63.9 Years STANDARD_DEVIATION 11.2 | — |
| Body Mass Index, Continuous | 27.9 kg/m2 STANDARD_DEVIATION 3.9 | — |
| CHA2DS2VASc score, Categorical | 2.7 units on a scale [scale range: 0-9] STANDARD_DEVIATION 1.9 | — |
| Left Atrial Diameter | 4.4 cm | — |
| Left Atrial Volume Index | 40 mL/m2 | — |
| Left Ventricular Ejection Fraction, Continuous | 55 % | — |
| Long-standing persistent AF | 2 Participants | — |
| Paroxysmal AF | 9 Participants | — |
| Persistent Atrial Fibrillation | 14 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Netherlands | 6 participants | — |
| Region of Enrollment Poland | 10 participants | — |
| Region of Enrollment United States | 9 participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 0 / 13 | 1 / 12 |
| serious Total, serious adverse events | 0 / 13 | 1 / 12 |
Outcome results
Primary
Number of Participants With Acute Procedure Success
Acute Procedure Success is defined as targeting and successful elimination of significant sources of electrographic flow (EGF) through radiofrequency ablation. EGF-identified sources are significant when their leading source activity is ≥ 26%. Successful elimination is defined as reduction of the source activity of the leading source to \<26% upon post-ablation remapping using EGF mapping.
Time frame: During the procedure
Population: Subjects treated optimally per protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects With EGF Identified Sources | Number of Participants With Acute Procedure Success | 13 Participants |
Secondary
Number of Participants With 12-month Freedom From AF Recurrence
This measure represents the number of subjects with freedom from documented episodes of atrial fibrillation (AF) recurrence lasting longer than 30 seconds from the 90-day post-procedure blanking period through 12 months of follow-up. Only subjects with completed 12 month follow-up are included in this analysis.
Time frame: 90 day - 12 months
Population: The analysis population for the secondary outcome consisted of two groups:~Group 1: Subjects who received EGF-guided ablation~Group 2: Subjects who did not receive EGF-guided ablation, which included:~* Subjects not inducible in AF after pulmonary vein isolation, preventing EGF mapping~* Subjects with no EGF-identified sources above threshold (≥26%) on EGF mapping~* Subjects where the physician elected not to ablate an EGF-identified source above threshold
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subjects With EGF Identified Sources | Number of Participants With 12-month Freedom From AF Recurrence | 8 Participants |
| Subjects That Did Not Receive EGF-guided Ablation | Number of Participants With 12-month Freedom From AF Recurrence | 6 Participants |