NCT07092774

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)

Real-World Safety and Effectiveness of Catheter Ablation of Paroxysmal Atrial Fibrillation as Initial Rhythm Control Therapy With the THERMOCOOL SMARTTOUCH SF Catheter - A Sub-study of REAL AF Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 344 (actual)
• Sponsor: Heart Rhythm Clinical and Research Solutions, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Paroxysmal Atrial Fibrillation (PAF)

Interventions

Type	Name	Description
DEVICE	Ablation	Ablation procedure using the Thermocool Smarttouch SF

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-07-30
• Last updated: 2025-10-31

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study