Fact CheckerSign in

NCT06144632Completed

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

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

Source: ClinicalTrials.gov · Last updated 16 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
237 (actual)
First submitted
17 Nov 2023
Start date
7 Dec 2023
Primary completion date
30 Oct 2025
Lead sponsor
Biosense Webster, Inc.
NCT number
NCT06144632

What you commit to

  • Study type: Interventional
  • Participants enrolled: 237
  • From 7 Dec 2023 to the primary completion date, 30 Oct 2025
  • 29 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
  • Previous left atrium (LA) ablation or surgery
  • Documented severe dilatation of the LA (left anterior descending artery \[LAD\] \>50mm) antero-posterior diameter on imaging within 6 months prior to enrollment
  • History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin) except subjects with prior left atrial appendage closure
  • Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days)
  • Prior diagnosis of pulmonary vein stenosis
  • Current enrollment in an investigational study evaluating another device or drug

Other illness

  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)
  • Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
  • Participants with unstable angina, percutaneous coronary intervention or acute myocardial infarction within 2 months
  • Valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
  • Unstable angina within 6 months
  • Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
  • Significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
  • Acute illness, active systemic infection, or sepsis
  • Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD), recently implanted (within 6 months) left atrial appendage occlusion (LAAO) device or other implanted metal cardiac device within cardiac space that may interfere with the energy field created during the ablation procedure
  • Presence of a condition that precludes vascular access

Lab values

  • Documented severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40 percent \[%\]) by imaging within 6 months prior to enrollment

Age

  • Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation

Other

  • Participants known to require ablation outside the pulmonary vein (PV) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia, and Wolff-Parkinson-White), except cavotricuspid isthmus (CTI) lines for the ablation of typical right atrial flutter
  • Documented LA thrombus by imaging within 48 hours of the procedure
  • Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 12 months
  • Significant congenital anomaly (for example, atrial septal defects \[ASDs\]) including repaired defects or medical problem that in the opinion of the investigator would preclude enrollment in this study
  • Pre-existing hemi diaphragmatic paralysis
  • Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
  • Severe mitral regurgitation (Regurgitant volume greater than or equal to \[\>=\] 60 milli liter (mL)/beat, Regurgitant fraction \>= 50%, and/or Effective regurgitant orifice area \>= 0.40 cm\^2)
  • Life expectancy less than 12 months
  • Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)

Who the study is looking for

  • Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) with (a) at least two symptomatic atrial fibrillation (AF) episodes within last six months from enrollment and (b) at least one AF episode electrocardiographically documented by electrocardiogram (ECG); transtelephonic monitoring (TTM), Holter monitor, telemetry strip or implanted device within 12 months prior to enrollment
  • Failed at least one antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable side effects to the AAD, or contraindication to the AAD
  • Willing and capable of providing consent
  • Able and willing to comply with all pre-, post- and follow-up testing and requirements

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
HCA Florida JFK Hospital
Coordinator of this site? Confirm its status
AtlantisUnited StatesUnknown status
Texas Cardiac Arrhythmia Research Foundation
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Grandview Medical Center
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Massachusetts General
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Rush University Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
University Hospitals Cleveland Medical Center*
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Ohio Health Research Institute
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Ohio State University
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Cardiovascular Associates of the Delaware Valley
Coordinator of this site? Confirm its status
Haddon HeightsUnited StatesUnknown status
Ascension St. Vincent's
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
University of Kansas Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
Baptist Health Lexington
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status
Keck School of Medicine of USC
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Norton Heart Specialist
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status
Georgia Arrhythmia Consultants and Research Institute
Coordinator of this site? Confirm its status
MaconUnited StatesUnknown status
Loyola University Medical Center
Coordinator of this site? Confirm its status
MaywoodUnited StatesUnknown status
HCA Florida Mercy Hospital
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Sentara Norfolk General Hospital
Coordinator of this site? Confirm its status
NorfolkUnited StatesUnknown status
Trident Medical Center
Coordinator of this site? Confirm its status
North CharlestonUnited StatesUnknown status
The Kansas City Heart Rhythm Institute
Coordinator of this site? Confirm its status
Overland ParkUnited StatesUnknown status
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Coordinator of this site? Confirm its status
PlanoUnited StatesUnknown status
Methodist Texsan
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Sarasota Memorial Hospital
Coordinator of this site? Confirm its status
SarasotaUnited StatesUnknown status
Memorial Health University Medical Center
Coordinator of this site? Confirm its status
SavannahUnited StatesUnknown status
Montefiore Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status
Wake Forest Baptist Medical Center
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status
Trinity Health Michigan Heart - Ann Arbor Campus
Coordinator of this site? Confirm its status
YpsilantiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.