Atrial Fibrillation
Conditions
Keywords
FIRM procedure
Brief summary
This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation. FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView® mapping system. In addition to the FIRM guided ablation any other ablation method could be applied.The acute success of FIRM ablations is defined as elimination of rotors defined by absence of rotors. 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 is 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Success | day of procedure | Acute Success was defined as the elimination (by ablation) of all identified rotors |
| Number of Participants With 12-Month Success | 12-months after index procedure | Single procedure freedom from atrial fibrillation recurrence |
| Number of Participants With Acute Safety Success | 7 days after index procedure | Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure |
| Number of Participants With 12-Month Safety Success | 12-months after index procedure | Success was defined as freedom from Serious Adverse 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 | Success was defined as freedom from Serious Adverse Events at 6-months after index procedure |
Countries
Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Registry Population All patients enrolled in the registry | 299 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Did not complete 12-month follow-up | 72 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Not treated | 14 |
| Overall Study | Repeat Procedure | 10 |
Baseline characteristics
| Characteristic | Registry Population | — |
|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 9 | — |
| Body Mass Index | 29.5 kg/m^2 STANDARD_DEVIATION 4.9 | — |
| Left Atrium Diamter | 47.2 millimeter STANDARD_DEVIATION 6.1 | — |
| Left Ventricle Ejection Fraction | 55.8 percent STANDARD_DEVIATION 8.5 | — |
| New York Heart Association Class Class I | 94 Participants | — |
| New York Heart Association Class Class II | 79 Participants | — |
| New York Heart Association Class Class III | 37 Participants | — |
| New York Heart Association Class Not reported | 89 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 95 Participants | — |
| Sex: Female, Male Male | 204 Participants | — |
| Type of Atrial Fibrillation Long lasting | 11 Participants | — |
| Type of Atrial Fibrillation Not reported | 2 Participants | — |
| Type of Atrial Fibrillation Paroxysmal | 38 Participants | — |
| Type of Atrial Fibrillation Persistent | 248 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 299 |
| other Total, other adverse events | 0 / 299 |
| serious Total, serious adverse events | 34 / 299 |
Outcome results
Primary
Number of Participants With 12-Month Safety Success
Success was defined as freedom from Serious Adverse Events at 12-months after index procedure
Time frame: 12-months after index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Analysis Population | Number of Participants With 12-Month Safety Success | 184 Participants |
Primary
Number of Participants With 12-Month Success
Single procedure freedom from atrial fibrillation recurrence
Time frame: 12-months after index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Analysis Population | Number of Participants With 12-Month Success | 101 Participants |
Primary
Number of Participants With Acute Safety Success
Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure
Time frame: 7 days after index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Analysis Population | Number of Participants With Acute Safety Success | 257 Participants |
Primary
Number of Participants With Acute Success
Acute Success was defined as the elimination (by ablation) of all identified rotors
Time frame: day of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Analysis Population | Number of Participants With Acute Success | 165 Participants |
Other Pre-specified
Number of Participants With 6-Month Safety Success
Success was defined as freedom from Serious Adverse Events at 6-months after index procedure
Time frame: 6-months after index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Analysis Population | Number of Participants With 6-Month Safety Success | 232 Participants |