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

• ClinicalTrials.gov Identifier: NCT05752487
• Recruitment Status: Active, not recruiting
• First Posted: March 2, 2023
• Last Update Posted: April 24, 2024
• Sponsor: Biosense Webster, Inc.
• Information provided by (Responsible Party): Biosense Webster, Inc.

Tracking Information

• First Submitted Date: February 22, 2023
• First Posted Date: March 2, 2023
• Last Update Posted Date: April 24, 2024
• Actual Study Start Date: February 27, 2023
• Actual Primary Completion Date: September 25, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 22, 2023)

• Number of Participants with Incidence of Primary Adverse Events (PAE's) [ Time Frame: Within 7 days post-procedure ]
  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.
• Percentage of Participants with Acute Procedural Success [ Time Frame: Immediate post-procedure ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 22, 2023)

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) 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator
• Official Title: Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
• Brief 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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).

Study Arms

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

Participants with drug refractory, paroxysmal atrial fibrillation (PAF) who are candidates for catheter ablation will be enrolled with ablation system which uses THERMOCOOL SMARTTOUCH SF (STSF) catheter and TRUPULSE generator to deliver RF or PF energy during cardiac ablation procedures.

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 8, 2023): 145
• Original Estimated Enrollment (submitted: February 22, 2023): 135
• Estimated Study Completion Date: November 1, 2024
• Actual Primary Completion Date: September 25, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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])

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Denmark, Lithuania

Administrative Information

• NCT Number: NCT05752487
• Other Study ID Numbers: BWI202202; BWI202202 ( Other Identifier: Biosense Webster, Inc. )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
• URL: https://www.janssen.com/clinical-trials/transparency

• Current Responsible Party: Biosense Webster, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Biosense Webster, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Biosense Webster, Inc. Clinical Trial; Biosense Webster, Inc.

• PRS Account: Biosense Webster, Inc.
• Verification Date: April 2024