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Completed Not applicable Interventional

A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF

ClinicalTrials.gov ID: NCT06144632

Public ClinicalTrials.gov record NCT06144632. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 6:51 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation (PAF)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.

Study identification

NCT ID
NCT06144632
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Biosense Webster, Inc.
Industry
Enrollment
237 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 7, 2023 (Actual)
Primary completion
Oct 30, 2025 (Actual)
Completion
Oct 30, 2025 (Actual)
Last update posted
Jan 16, 2026

2023 – 2025

United States locations

U.S. sites
29
U.S. states
16
U.S. cities
27
Facility City State ZIP Site status
Grandview Medical Center Birmingham Alabama 35243 —
University of Alabama at Birmingham Birmingham Alabama 35294 —
Keck School of Medicine of USC Los Angeles California 90033 —
HCA Florida JFK Hospital Atlantis Florida 33462 —
Ascension St. Vincent's Jacksonville Florida 32204 —
HCA Florida Mercy Hospital Miami Florida 33133 —
Sarasota Memorial Hospital Sarasota Florida 34239 —
Georgia Arrhythmia Consultants and Research Institute Macon Georgia 31201 —
Memorial Health University Medical Center Savannah Georgia 31404 —
Rush University Medical Center Chicago Illinois 60612 —
Loyola University Medical Center Maywood Illinois 60153 —
University of Kansas Medical Center Kansas City Kansas 66160 —
The Kansas City Heart Rhythm Institute Overland Park Kansas 66211 —
Baptist Health Lexington Lexington Kentucky 40503 —
Norton Heart Specialist Louisville Kentucky 40205 —
Massachusetts General Boston Massachusetts 02114 —
Trinity Health Michigan Heart - Ann Arbor Campus Ypsilanti Michigan 48197 —
Cardiovascular Associates of the Delaware Valley Haddon Heights New Jersey 08035 —
NYU Langone Health New York New York 10016 —
Montefiore Medical Center The Bronx New York 10467 —
Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157 —
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 —
Ohio State University Columbus Ohio 43210 —
Ohio Health Research Institute Columbus Ohio 43214 —
Trident Medical Center North Charleston South Carolina 29406 —
Texas Cardiac Arrhythmia Research Foundation Austin Texas 78705 —
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano Plano Texas 75093 —
Methodist Texsan San Antonio Texas 78201 —
Sentara Norfolk General Hospital Norfolk Virginia 23507 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06144632, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 16, 2026 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06144632 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →