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
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
1 other identifier
observational
344
1 country
12
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 22, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedOctober 31, 2025
October 1, 2025
1.7 years
July 22, 2025
October 29, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Primary effectiveness
Freedom from atrial arrhythmia recurrence
12-months
Primary effectiveness
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.
Post 3-month blanking period
Primary safety
A composite of procedure or device related adverse events post index ablation.
7 days
Primary safety
Atrio-esophageal fistula, severe pulmonary vein stenosis and device or procedure related death post index ablation
90 days
Primary safety
Cardiac tamponade/pericardial effusion post index ablation
30 days
Interventions
Ablation procedure using the Thermocool Smarttouch SF
Eligibility Criteria
The sub-study population will consist of Class I/III AAD naïve PAF patients who underwent ablation procedure using the THERMOCOOL STSF Catheter as their first rhythm control therapy. The study 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 months follow-up as standard-of-care.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Arrhythmia Institute at Grandview
Birmingham, Alabama, 35243, United States
Community Memorial Hospital
Ventura, California, 93303, United States
Ascension St. Vincent's
Jacksonville, Florida, 32204, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Northshore University Health System
Evanston, Illinois, 60201, United States
Ascension St. Vincent's Hospital
Indianapolis, Indiana, 46260, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Mount Carmel Columbus Cardiology Consultants
Columbus, Ohio, 43213, United States
University of Pennsylvania, Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15222, United States
Upstate Cardiology
Greenville, South Carolina, 29607, United States
Centra Health, Inc. (dba Stroobants Cardiovascular Center)
Lynchburg, Virginia, 24501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2025
First Posted
July 30, 2025
Study Start
April 1, 2024
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
October 31, 2025
Record last verified: 2025-10