Atrial Fibrillation
Conditions
Keywords
Ablation, Radiofrequency
Brief summary
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
Interventions
DEVICEAblation
Ablation procedure for Atrial Fibrillation
Sponsors
Abbott
Heart Rhythm Clinical and Research Solutions, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who, in the opinion of the investigator, are candidates for ablation to treat atrial fibrillation. * Plans to undergo an ablation procedure using the TactiFlex Ablation Catheter™, Sensor Enabled™ (TactiFlex SE) manufactured by Abbott. * De Novo or redo AF catheter ablation procedures. * Able and willing to participate in baseline and all follow up evaluations. * 18 years of age or older.
Exclusion criteria
* Enrolled in any other cardiac device clinical trial, investigational drug trial, or any other trial that may confound the results of the ablation procedure. * In the opinion of the investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long term effectiveness | 12-month | defined as freedom from recurrence of AF/AT/AFL \>30 sec at 12-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute success | at time of procedure | ability to obtain pulmonary vein isolation during the ablation using TactiFlex catheter only |
| Acute safety | 30 days | 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 |
| Long term safety | 12 months | Rate of long-term safety events defined as procedure or device related complications that occur greater than 30 days post ablation. |
Contacts
Primary ContactKim Harbin
Backup ContactCourtney Muenchow
Outcome results
None listed