Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: 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)

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Paroxysmal Atrial Fibrillation (PAF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrhythmia Institute at Grandview, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ablation

Device

Ablation procedure using the Thermocool Smarttouch SF

Primary outcomes

  1. Primary effectiveness

    Time frame: 12-months

    Freedom from atrial arrhythmia recurrence

  2. Primary effectiveness

    Time frame: Post 3-month blanking period

    Any repeat ablation procedure, use of class I/III AAD, or cardioversion post-blanking for treatment of atrial arrhythmia will be deemed failure of primary effectiveness endpoint.

  3. Primary safety

    Time frame: 7 days

    A composite of procedure or device related adverse events post index ablation.

  4. Primary safety

    Time frame: 90 days

    Atrio-esophageal fistula, severe pulmonary vein stenosis and device or procedure related death post index ablation

  5. Primary safety

    Time frame: 30 days

    Cardiac tamponade/pericardial effusion post index ablation

Sponsors and collaborators

Lead sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Official study title

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

Acronym: First Line

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.