Clinical trial NCT06272981: A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-22
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria::

* Diagnosed with Symptomatic PAF (Physician's note indicating recurrent self-terminating AF). At least one (1) electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), Holter monitor, or other electrocardiographical devices accepted by investigators
* Failed at least one (1) Class I or Class III Antiarrhythmic Drug (AAD) as evidenced by recurrent symptomatic AF or has intolerable side effects or is contraindicated to the Class I or Class III AAD
* Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements
* Willing and capable of providing consent

Exclusion Criteria:

* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (e.g., untreated documented obstructive sleep apnea and acute alcohol toxicity)
* Previous LA ablation or surgery
* Patients known to require ablation outside the PV region (atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White)
* Previously diagnosed with persistent AF (\> 7 days in duration)
* Severe dilatation of the LA (documented LAD \>50mm antero-posterior diameter on imaging within 6 months prior to enrollment
* Documented left atrium (LA) thrombus within 48 hours prior to the index procedure by Transesophageal Echocardiography (TEE), or by Intracardiac Echocardiography (ICE) prior to transeptal puncture during procedure
* Documented severely compromised LVEF (LVEF \<40%) 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, warfarin, or dabigatran)
* History of a documented thromboembolic event (including TIA) within the past 12 months, or history of a documented left atrial appendage (LAA) thrombus
* History of a documented symptomatic lacunar infarction within the past 12 months
* Previous PCI/MI within the past 2 months
* Coronary Artery Bypass Grafting (CABG) surgery within past 6 months
* Valvular surgery, cardiac surgery (e.g., ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
* Unstable angina pectoris within the past 6 months
* Anticipated cardiac transplantation, cardiac surgery or other major surgery within the next 12 months
* Significant pulmonary disease (e.g., 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
* Known significant PV anomaly that in the opinion of the investigator would preclude enrollment in this study
* Has known 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 60 mL/beat, Regurgitant fraction 50%, and/or Effective regurgitant orifice area 0.40cm\^2)
* Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD), recently implanted (within 6 months) LAAO device or other implanted metal cardiac device within the cardiac space that may interfere with the energy field created during the ablation procedure.
* Presence of a condition that precludes vascular access (such as IVC filter)
* Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this study
* Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
* 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 childbearing age and plan on becoming pregnant during the course of the clinical investigation
* Life expectancy less than 12 months
* History of massive hemorrhage within the past 6 months
* Presenting contra-indications for the devices

Primary outcomes:
measure: Number of Participants with Primary Adverse Events (PAEs)
timeFrame: Within one week (7 days) post-procedure
measure: Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of Unknown Origin) within 91-365 Days Post Index Procedure
timeFrame: Within Day 91 to Day 365 post-procedure
Secondary outcomes:
measure: Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Garran
country: Australia
facility: Canberra Heart Rhythm
city: Westmead
country: Australia
facility: Westmead Hospital
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: Biosense Webster, Inc.
name: Biosense Webster, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: