Atrial Fibrillation
Conditions
Brief summary
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of St. Jude Medical (SJM)/Abbott mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).
Detailed description
The objectives of this registry are the following: * To confirm patient safety as part of the post market surveillance study. * To assess performance of a combination of SJM products during procedures. * To assess the learning curve with a combination of SJM products. * To collect operator feedback on a combination of SJM products. All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry. In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.
Interventions
OTHERObservation / Data Collection
The following data will be reviewed / collected: Baseline Visit: Patient demographics; Atrial fibrillation History; Cardiovascular history; Cardiac medical history. Ablation Procedure: Devices used; Ablation parameters; Ablation success definition and result; Operator feedback (Device combination chosen, device maneuverability, ease of use in combination with other device); Number, experience and type of attending personnel; Definition of standard of care (follow-up procedures and occurrence). 6- and 12-month follow-up (+/- 30 DAYS): Recurrence of atrial arrhythmias: list of atrial arrhythmias since last visit, classify episodes, duration of the episodes; Changes in therapy; In case of Repeat Ablation Procedures, reconnections and new ablations will be recorded.
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients who are indicated for an atrial fibrillation ablation procedure.
Exclusion criteria
* Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unsuccessful Treatment Rate | up to 6 and 12 months after ablation procedure | Percent of subjects with a repeat procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Serious Adverse Event (SAE) | up to 6 and 12 months after ablation procedure | Percent of subjects with Cardiovascular SAE. |
| Death in Subjects Who Underwent an Ablation Procedure | up to 12 months after ablation procedure | Percent of subjects experiencing death within 12 months of ablation procedure |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Patients who have indication for ablation of atrial fibrillation and who were willing to provide a written consent form, except pregnant women, were included in this registry. Patients were considered enrolled in this registry at the time they signed the written consent form. | 833 |
| Total | 833 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Duplicate subject | 1 |
| Overall Study | Inclusion/Exclusion Criteria Not Met | 7 |
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Re-ablation | 1 |
| Overall Study | Sponsor Request | 1 |
Baseline characteristics
| Characteristic | Enrolled | — |
|---|---|---|
| Age, Customized <29 years | 16 Participants | — |
| Age, Customized 30-39 years | 61 Participants | — |
| Age, Customized 40-49 years | 97 Participants | — |
| Age, Customized 50-59 years | 220 Participants | — |
| Age, Customized 60-69 years | 279 Participants | — |
| Age, Customized 70-79 years | 145 Participants | — |
| Age, Customized >80 years | 15 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 228 Participants | — |
| Sex: Female, Male Male | 605 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 833 |
| other Total, other adverse events | 1 / 833 |
| serious Total, serious adverse events | 30 / 833 |
Outcome results
Primary
Unsuccessful Treatment Rate
Percent of subjects with a repeat procedure
Time frame: up to 6 and 12 months after ablation procedure
Population: The analysis population is subjects who received atrial fibrillation (AF) ablation for which 6-month and 12-month follow-up data was available for, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Unsuccessful Treatment Rate | 6 months | 22 Participants |
| Enrolled | Unsuccessful Treatment Rate | 12 months | 21 Participants |
Secondary
Cardiovascular Serious Adverse Event (SAE)
Percent of subjects with Cardiovascular SAE.
Time frame: up to 6 and 12 months after ablation procedure
Population: The analysis population is subjects who received AF ablation for which 6-month and 12-month follow-up data was available for, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Cardiovascular Serious Adverse Event (SAE) | 6 months | 2 Participants |
| Enrolled | Cardiovascular Serious Adverse Event (SAE) | 12 months | 2 Participants |
Secondary
Death in Subjects Who Underwent an Ablation Procedure
Percent of subjects experiencing death within 12 months of ablation procedure
Time frame: up to 12 months after ablation procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled | Death in Subjects Who Underwent an Ablation Procedure | Death <30 days post-procedure | 3 Participants |
| Enrolled | Death in Subjects Who Underwent an Ablation Procedure | Death >30 days post-procedure | 2 Participants |