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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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An observational, prospective, multi-center, non-randomized registry designed to obtain real world clinical experience with the TactiFlex Catheter Ablation system in the treatment of Atrial Fibrillation. Patient assessments will occur at pre procedure and procedure, and 1 year post ablation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing AF Ablation using TactiFlex catheter | patients undergoing de novo or redo AF ablation procedures using TactiFlex ablation catheter following patients up to 6 to 12 months follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablation | Device | Ablation procedure for Atrial Fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long term effectiveness | defined as freedom from recurrence of AF/AT/AFL >30 sec at 12-month follow-up | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| Acute success | ability to obtain pulmonary vein isolation during the ablation using TactiFlex catheter only | at time of procedure |
| Acute safety | rate of acute safety events defined as procedure or device related complications that occur within 7 days of the procedure and incidence per-procedural complications that occur greater than 7 days but less than 30 days post ablation |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with atrial fibrillation undergoing ablation at selected sites who meet eligibility. Site in US, Canda, and OUS
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kim Harbin | Contact | 256-591-0727 | kharbin@hrcrs.com | |
| Courtney Muenchow | Contact | cmuenchow@hrcrs.com |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 30 days |
| Long term safety | Rate of long-term safety events defined as procedure or device related complications that occur greater than 30 days post ablation. | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |