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Completed

NCT Number: NCT05752487

A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator

The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) defined as atrial fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset. This PAF is considered to be symptomatic if symptoms related to AF are experienced by the participant
  • Selected for AF ablation procedure by pulmonary vein isolation (PVI)
  • Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic AF, or intolerable or contraindicated 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

  • Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity {Body Mass Index greater than [>] 40 kilograms per meter square [kg/m²]}, renal insufficiency (with an estimated creatinine clearance less than [<] 30 milliliters [mL]/ minute [min]/1.73 meter square [m2] )
  • Previous left atrium (LA) ablation or surgery
  • Patients known to require ablation outside the pulmonary vein (PV) region (example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, ventricular tachycardia and wolff-parkinson-white)
  • Previously diagnosed with persistent AF [greater than (>) 7 days in duration]
  • Severe dilatation of the left atrium (LA) (Left anterior descending artery [LAD] >50mm antero-posterior diameter in case of Transthoracic Echocardiography [TTE])

Treatment and study plan

Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation

Device

Participants will undergo catheter ablation with the PF /RF ablation system consisting of the TRUPULSE Generator (delivers RF or PF energy through the study catheter) and the THERMOCOOL SMARTTOUCH SF (STSF) Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a Generator, for cardiac ablation).

Primary outcomes

  1. Percentage of Participants With Primary Adverse Events (PAEs)

    Time frame: 90 days post-procedure on Day 1

    Percentage of participants with PAEs (within 7 days following the ablation procedure) was reported. PAEs included the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (that occurred greater than 7 days and less than or equal to 90 days post-procedure), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.

  2. Percentage of Participants With Acute Procedural Success

    Time frame: Immediately post-procedure on Day 1

    Percentage of participants with acute procedural success were reported. Procedural success was defined as electrical isolation of clinically relevant targeted pulmonary veins (PVs) (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure.

Secondary outcomes

  1. Percentage of Participants With Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia

    Time frame: Day 91 to Day 365

    Percentage of participants with freedom from documented (symptomatic and asymptomatic) atrial arrhythmia episodes including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; unknown origin) episodes based on electrocardiographic data (greater than equal to [>=]30 seconds on arrhythmia monitoring device) were reported. Participants with an AF/AT/AFL (of unknown origin) episode that is >=30 seconds on arrhythmia monitoring device during the evaluation period were considered failures of this long-term effectiveness outcome measure. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the targeted pulmonary vein [PVs]) were also deemed a failure of this outcome measure. AFL of unknown origin was defined as all AFL except those cavotricuspid isthmus (CTI) dependent AFL as confirmed by 12-lead electrocardiogram (ECG) or entrainment maneuvers in an electrophysiology (EP) study.

Sponsors and collaborators

Lead sponsor

Biosense Webster, Inc.

Industry

Registry information

Official study title

Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)

Acronym: SmartfIRE

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 2, 2023
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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