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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07092774

Acronym

First Line

Enrollment

344

Registered

2025-07-30

Start date

2024-04-01

Completion date

2025-12-31

Last updated

2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Brief 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.

Interventions

DEVICEAblation

Ablation procedure using the Thermocool Smarttouch SF

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary effectiveness	12-months	Freedom from atrial arrhythmia recurrence
Primary safety	7 days	A composite of procedure or device related adverse events post index ablation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026