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.
- Diseases
- Atrial fibrillation
- 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
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HCA Florida JFK Hospital Coordinator of this site? Confirm its status | Atlantis | United States | Unknown status |
| Texas Cardiac Arrhythmia Research Foundation Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Grandview Medical Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Massachusetts General Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Ohio Health Research Institute Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Cardiovascular Associates of the Delaware Valley Coordinator of this site? Confirm its status | Haddon Heights | United States | Unknown status |
| Ascension St. Vincent's Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Baptist Health Lexington Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Keck School of Medicine of USC Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Heart Specialist Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Georgia Arrhythmia Consultants and Research Institute Coordinator of this site? Confirm its status | Macon | United States | Unknown status |
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| HCA Florida Mercy Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Sentara Norfolk General Hospital Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Trident Medical Center Coordinator of this site? Confirm its status | North Charleston | United States | Unknown status |
| The Kansas City Heart Rhythm Institute Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Methodist Texsan Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Sarasota Memorial Hospital Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Memorial Health University Medical Center Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Wake Forest Baptist Medical Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
| Trinity Health Michigan Heart - Ann Arbor Campus Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.