NCT06272981CompletedNot Applicable
Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Biosense Webster, Inc.14 sites in 2 countries135 target enrollmentStarted: February 28, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biosense Webster, Inc.
- Enrollment
- 135
- Locations
- 14
- Primary Endpoint
- Number of Participants with Primary Adverse Events (PAEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of Participants with Primary Adverse Events (PAEs)
Time Frame: Within one week (7 days) post-procedure
PAEs occurring within 7 days of an ablation which uses the BWI ablation system (including atrio-esophageal fistula and pulmonary vein stenosis occurring greater than 7 days of post ablation procedure) will be reported.
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
Time Frame: Within Day 91 to Day 365 post-procedure
Rate of Freedom from documented (symptomatic and asymptomatic) atrial arrhythmia (AF, AT or AFL of unknown origin) within 91-365 days post index procedure will be reported. Freedom from atrial arrhythmia will be reported based on electrocardiographic data (greater than or equal to \[\>=30\] seconds on arrhythmia monitoring device) during the effectiveness evaluation period (Day 91-Day 365) off antiarrhythmic therapy.
Secondary Outcomes
- Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score(Baseline, Month 12)
Investigators
Study Sites (14)
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