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

Atrial Fibrillation Clinical Trial

— SmartfIRE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05752487
• Other study ID #: BWI202202
• Secondary ID: BWI202202
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2024
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 145
• Est. completion date: November 1, 2024
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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])

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
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).

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Austria	Ordensklinikum Linz GmbH Elisabethinen	Linz
Belgium	O L V Ziekenhuis	Aalst
Belgium	AZ Sint-Jan	Brugge
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Jessa Ziekenhuis	Hasselt
Denmark	Aarhus University Hospital	Aarhus
Denmark	Gentofte Hospital	Hellerup
Denmark	Odense University Hospital	Odense C
Lithuania	Vilnius University Hospital Santaros Clinics	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Incidence of Primary Adverse Events (PAE's)	Number of Participants with incidence of PAEs (within 7 days following the ablation procedure) will be reported. PAE's will include the following adverse events atrio-esophageal fistula, pulmonary vein stenosis, device or procedure related death, (that occur 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.	Within 7 days post-procedure
Primary	Percentage of Participants with Acute Procedural Success	Percentage of participants with acute procedural success will be reported. It is 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. Use of a non-study device to achieve PV isolation is considered an acute procedural failure.	Immediate post-procedure
Secondary	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	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) on or off antiarrhythmic therapy. Acute procedural failure (that is, failure to achieve entrance block with the study device in any of the clinically relevant targeted PVs) will also be deemed a 12 month effectiveness failure.	Within day 91 to day 365 post-procedure