Atrial Fibrillation
Conditions
Brief summary
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM 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
None listed
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 |
|---|---|---|
| Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period. | 12 months post procedure | Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure. |
| Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs. | 12 months post procedure | Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin (Cardiovascular Serious Adverse Event) with the potential of leading to: * Death * A serious deterioration in the health of the subject * Fetal distress, fetal death or a congenital abnormality or birth defect A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required. |
Countries
Austria, Belgium, Canada, China, Czechia, France, Germany, India, Italy, Netherlands, Portugal, Saudi Arabia, South Korea, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects Subjects enrolled in the registry were already planned to undergo an ablation procedure for AF (including both first ablation and repeat ablations). Subjects were considered enrolled upon providing written informed consent. | 2,035 |
| Total | 2,035 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12-month Visit | Death | 8 |
| 12-month Visit | Lost to Follow-up | 58 |
| 12-month Visit | Withdrawal by Subject | 30 |
| Procedure | Ablation Procedure Not Performed | 7 |
Baseline characteristics
| Characteristic | All Enrolled Subjects | — |
|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 10.4 | — |
| Had Prior AF Ablation No | 447 Participants | — |
| Had Prior AF Ablation Yes | 1581 Participants | — |
| Indication for procedure Paroxysmal AF | 1151 Participants | — |
| Indication for procedure Permanent AF | 131 Participants | — |
| Indication for procedure Persistent AF | 746 Participants | — |
| Left Atrial Diameter | 42.5 mm STANDARD_DEVIATION 11.2 | — |
| Left Atrial Volume | 76 mL STANDARD_DEVIATION 39.7 | — |
| Percentage of Left Ventricular Ejection Fraction | 58.7 % STANDARD_DEVIATION 9.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 639 Participants | — |
| Sex: Female, Male Male | 1393 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 2,035 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 356 / 2,035 |
Outcome results
Primary
Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period.
Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure.
Time frame: 12 months post procedure
Population: Subjects that completed 12-month visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Per-Protocol | Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period. | 1297 Participants |
Primary
Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period.
Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure.
Time frame: 12 months post procedure
Population: Treated Subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Per-Protocol | Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period. | 1297 Participants |
Primary
Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs.
Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin (Cardiovascular Serious Adverse Event) with the potential of leading to: * Death * A serious deterioration in the health of the subject * Fetal distress, fetal death or a congenital abnormality or birth defect A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required.
Time frame: 12 months post procedure
Population: Enrolled subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Per-Protocol | Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs. | 43 Participants |