Real-world Safety and Effectiveness Registry of Catheter Ablation of Paroxysmal Atrial Fibrillation as Initial Control Therapy With the Thermocool SmartTouch SF Catheter (A Sub-study of REAL AF Registry) (First Line)

Heart Rhythm Clinical and Research Solutions (HRCRS)

Status: Active, not recruiting

Conditions: Paroxysmal Atrial Fibrillation (PAF)

Treatments: Device: Ablation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07092774

BWI-CS-004-F

Details and patient eligibility

About

To generate real-world evidence from the parent study, REAL AF registry, on the use of Thermocool SmartTouch SF (STSF) catheter in ablation for the treatment of paroxysmal atrial fibrillation (PAF).

Full description

The primary objective of this registry is to evaluate effectiveness and safety of Thermocool STSF catheter to support an indication extension of the STSF catheter using real world data from the REAL AF registry. Subjects included in the registry will be those in which the STSF catheter is used for the treatment of symptomatic PAF in antiarrhythmic drug (AAD) naive patients as an initial rhythm control therapy. The registry will involve retrospective analysis of data prospectively collected from the REAL AF registry. The registry will include consecutive, eligible patients from the REAL AF registry, starting from October 2021 who meet the sub-study eligibility criteria until 344 eligible subjects are identified. Eligible patients from all participating centers in the REAL AF registry will be included, except for sites with standard-of-care rhythm monitoring less than 48 hours and those that do not perform 6-12 month follow up as standard of care.

Enrollment: 344 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with symptomatic PAF
• First time ablation
• Ablation performed with the Thermocool STSF catheter
• Age 18 or over at the time of the index ablation procedure

Exclusion criteria

• Received Class I or III antiarrhythmic drug prior to the index ablation.
• Did not previously consent for their anonymized data to be used for research purposes.
• Rhythm monitoring less than 48 hours.