A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAF
NCT ID: NCT06144632
Last Updated: 2026-01-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
237 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-12-07
Study Completion Date
2025-10-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Drug Refractory Paroxysmal Atrial Fibrillation
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment Group
Participants with drug refractory, symptomatic paroxysmal atrial fibrillation will receive PFA /radiofrequency (RF) ablation using THERMOCOOL STSF catheter in conjunction with the TRUPULSE generator per the hospital's standard protocol (at discretion of investigator).
Group Type
EXPERIMENTAL
THERMOCOOL STSF Bi- Directional Navigation Catheter
Intervention Type
DEVICE
THERMOCOOL STSF will be used in conjunction with TRUPULSE Generator to give pulsed field (PF) ablation or radiofrequency (RF) ablation.
TRUPULSE Generator
Intervention Type
DEVICE
TRUPULSE Generator will be used to deliver PF/RF ablation.
Interventions
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THERMOCOOL STSF Bi- Directional Navigation Catheter
THERMOCOOL STSF will be used in conjunction with TRUPULSE Generator to give pulsed field (PF) ablation or radiofrequency (RF) ablation.
Intervention Type
DEVICE
TRUPULSE Generator
TRUPULSE Generator will be used to deliver PF/RF ablation.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)
* Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
* Previous left atrium (LA) ablation or surgery
* 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 severe dilatation of the LA (left anterior descending artery \[LAD\] \>50mm) antero-posterior diameter on imaging within 6 months prior to enrollment
* Documented LA thrombus by imaging within 48 hours of the procedure
* Documented severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40 percent \[%\]) by imaging within 6 months prior to enrollment
* Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin) except subjects with prior left atrial appendage closure
* Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 12 months
* Participants with unstable angina, percutaneous coronary intervention or acute myocardial infarction within 2 months
* Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days)
* 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
* 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
* Prior diagnosis of pulmonary vein stenosis
* Pre-existing hemi diaphragmatic paralysis
* Acute illness, active systemic infection, or sepsis
* 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)
* 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
* Current enrollment in an investigational study evaluating another device or drug
* 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
* 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)
* Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
* Previous left atrium (LA) ablation or surgery
* 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 severe dilatation of the LA (left anterior descending artery \[LAD\] \>50mm) antero-posterior diameter on imaging within 6 months prior to enrollment
* Documented LA thrombus by imaging within 48 hours of the procedure
* Documented severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40 percent \[%\]) by imaging within 6 months prior to enrollment
* Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin) except subjects with prior left atrial appendage closure
* Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 12 months
* Participants with unstable angina, percutaneous coronary intervention or acute myocardial infarction within 2 months
* Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days)
* 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
* 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
* Prior diagnosis of pulmonary vein stenosis
* Pre-existing hemi diaphragmatic paralysis
* Acute illness, active systemic infection, or sepsis
* 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)
* 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
* Current enrollment in an investigational study evaluating another device or drug
* 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
* 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)
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Biosense Webster Inc. Clinical Trial
Role: STUDY_DIRECTOR
Biosense Webster, Inc.
Locations
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Grandview Medical Center
Birmingham, Alabama, United States
Site Status
University of Alabama at Birmingham
Birmingham, Alabama, United States
Site Status
Keck School of Medicine of USC
Los Angeles, California, United States
Site Status
HCA Florida JFK Hospital
Atlantis, Florida, United States
Site Status
Ascension St. Vincent's
Jacksonville, Florida, United States
Site Status
HCA Florida Mercy Hospital
Miami, Florida, United States
Site Status
Sarasota Memorial Hospital
Sarasota, Florida, United States
Site Status
Georgia Arrhythmia Consultants and Research Institute
Macon, Georgia, United States
Site Status
Memorial Health University Medical Center
Savannah, Georgia, United States
Site Status
Rush University Medical Center
Chicago, Illinois, United States
Site Status
Loyola University Medical Center
Maywood, Illinois, United States
Site Status
University of Kansas Medical Center
Kansas City, Kansas, United States
Site Status
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Site Status
Baptist Health Lexington
Lexington, Kentucky, United States
Site Status
Norton Heart Specialist
Louisville, Kentucky, United States
Site Status
Massachusetts General
Boston, Massachusetts, United States
Site Status
Trinity Health Michigan Heart - Ann Arbor Campus
Ypsilanti, Michigan, United States
Site Status
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
Site Status
NYU Langone Health
New York, New York, United States
Site Status
Montefiore Medical Center
The Bronx, New York, United States
Site Status
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Site Status
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Site Status
Ohio State University
Columbus, Ohio, United States
Site Status
Ohio Health Research Institute
Columbus, Ohio, United States
Site Status
Trident Medical Center
North Charleston, South Carolina, United States
Site Status
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Site Status
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Plano, Texas, United States
Site Status
Methodist Texsan
San Antonio, Texas, United States
Site Status
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Site Status
Countries
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United States
References
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Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11.
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Bardy GH, Coltorti F, Stewart RB, Greene HL, Ivey TD. Catheter-mediated electrical ablation: the relation between current and pulse width on voltage breakdown and shock-wave generation. Circ Res. 1988 Aug;63(2):409-14. doi: 10.1161/01.res.63.2.409.
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DeSimone CV, Kapa S, Asirvatham SJ. Electroporation: past and future of catheter ablation. Circ Arrhythm Electrophysiol. 2014 Aug;7(4):573-5. doi: 10.1161/CIRCEP.114.001999. No abstract available.
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van Driel VJ, Neven K, van Wessel H, Vink A, Doevendans PA, Wittkampf FH. Low vulnerability of the right phrenic nerve to electroporation ablation. Heart Rhythm. 2015 Aug;12(8):1838-44. doi: 10.1016/j.hrthm.2015.05.012. Epub 2015 May 18.
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Reddy VY, Anter E, Rackauskas G, Peichl P, Koruth JS, Petru J, Funasako M, Minami K, Natale A, Jais P, Nakagawa H, Marinskis G, Aidietis A, Kautzner J, Neuzil P. Lattice-Tip Focal Ablation Catheter That Toggles Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation: A First-in-Human Trial. Circ Arrhythm Electrophysiol. 2020 Jun;13(6):e008718. doi: 10.1161/CIRCEP.120.008718. Epub 2020 May 8.
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Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, Cochet H, Minami K, Breskovic T, Sikiric I, Sediva L, Chovanec M, Koruth J, Jais P. Pulsed Field Ablation of Paroxysmal Atrial Fibrillation: 1-Year Outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021 May;7(5):614-627. doi: 10.1016/j.jacep.2021.02.014. Epub 2021 Apr 28.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BWI202204
Identifier Type: OTHER
Identifier Source: secondary_id
BWI202204
Identifier Type: -
Identifier Source: org_study_id
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