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

Completed · Not applicable

Conditions studied: Drug Refractory Paroxysmal Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06144632

Run by

Biosense Webster, Inc.

People needed

237

Starts

2023-12-07

Expected to finish

2025-10-30

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Grandview Medical Center — Birmingham, Alabama, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Keck School of Medicine of USC — Los Angeles, California, United States
• HCA Florida JFK Hospital — Atlantis, Florida, United States
• Ascension St. Vincent's — Jacksonville, Florida, United States
• HCA Florida Mercy Hospital — Miami, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Georgia Arrhythmia Consultants and Research Institute — Macon, Georgia, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• The Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Norton Heart Specialist — Louisville, Kentucky, United States
• Massachusetts General — Boston, Massachusetts, United States
• Trinity Health Michigan Heart - Ann Arbor Campus — Ypsilanti, Michigan, United States
• Cardiovascular Associates of the Delaware Valley — Haddon Heights, New Jersey, United States
• NYU Langone Health — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Ohio Health Research Institute — Columbus, Ohio, United States
• Trident Medical Center — North Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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