Atrial Fibrillation
Conditions
Brief summary
This is a control registry to the E-FIRM registry to track conventional atrial fibrillation (AF) procedures in terms of clinical usage, handling, and the safety and effectiveness for the treatment of symptomatic atrial fibrillation. Conventional AF ablation is defined as pulmonary vein isolation (PVI) and any additional ablation for AF according to the standard routine of the center. Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.
Detailed description
Prospective and retrospective enrollment possible
Interventions
None listed
Sponsors
I-Med-Pro GmbH
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation * attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication
Exclusion criteria
* women who are pregnant As this is a registry only data of patients will be included who have been treated according to the current AF guidelines and the daily routine of the center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Success | day of procedure | Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure |
| Number of Participants With 12-Month Effectiveness | 12 months after initial AF ablation | Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period. |
| Number of Participants With Acute Safety Success | 7 days after initial AF ablation | Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation |
| Number of Participants With 12-Month Safety Success | 12-months after index procedure | 12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 6-month Safety Success | 6-months after index procedure | 6-Month safety success was defined as freedom from Serious Adverse Events 6-months after index procedure |
Countries
Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Registry Population All participants enrolled in the C-FIRM registry. | 73 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete 12-month follow-up | 13 |
| Overall Study | Not treated | 13 |
Baseline characteristics
| Characteristic | Registry Population | — |
|---|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 9.7 | — |
| Body Mass Index | 29.0 kg/m^2 STANDARD_DEVIATION 5.1 | — |
| Left Atrium Diamter | 45.2 millimeter STANDARD_DEVIATION 7.5 | — |
| Left Ventricle Ejection Fraction | 57.8 percent STANDARD_DEVIATION 9 | — |
| New York Heart Association Class Class I | 21 Participants | — |
| New York Heart Association Class Class II | 20 Participants | — |
| New York Heart Association Class Class III | 5 Participants | — |
| New York Heart Association Class Not reported | 27 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 20 Participants | — |
| Sex: Female, Male Male | 53 Participants | — |
| Type of Atrial Fibrillation Not reported | 1 Participants | — |
| Type of Atrial Fibrillation Paroxysmal | 32 Participants | — |
| Type of Atrial Fibrillation Persistent | 40 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 73 |
| other Total, other adverse events | 0 / 73 |
| serious Total, serious adverse events | 3 / 73 |
Outcome results
Primary
Number of Participants With 12-Month Effectiveness
Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period.
Time frame: 12 months after initial AF ablation
Population: Treated patients with 12-month follow-up data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Analysis Population | Number of Participants With 12-Month Effectiveness | 34 Participants |
Primary
Number of Participants With 12-Month Safety Success
12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure
Time frame: 12-months after index procedure
Population: Treated patients for whom 12-month safety data is available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Analysis Population | Number of Participants With 12-Month Safety Success | 45 Participants |
Primary
Number of Participants With Acute Safety Success
Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation
Time frame: 7 days after initial AF ablation
Population: Analysis population for whom data are available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Analysis Population | Number of Participants With Acute Safety Success | 56 Participants |
Primary
Number of Participants With Acute Success
Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure
Time frame: day of procedure
Population: All treated patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Analysis Population | Number of Participants With Acute Success | 53 Participants |
Other Pre-specified
Number of Participants With 6-month Safety Success
6-Month safety success was defined as freedom from Serious Adverse Events 6-months after index procedure
Time frame: 6-months after index procedure
Population: Treated patients for whom 6-month safety data is available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Analysis Population | Number of Participants With 6-month Safety Success | 51 Participants |