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

NCT05752487 | Completed Results DMC FDA Device

• 1 other identifier: BWI202202
• Study Type: interventional
• Target: 149
• Locations: 4 countries
• Sites: 9

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Primary Adverse Events (PAEs)

  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.

  90 days post-procedure on Day 1

• Percentage of Participants With Acute Procedural Success

  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.

  Immediately post-procedure on Day 1

Secondary Outcomes (1)

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

  Day 91 to Day 365

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

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).

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[TTE\])

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (9)

Medical University Graz

Graz, 8036, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen

Linz, 4020, Austria

Location

O L V Ziekenhuis

Aalst, 9300, Belgium

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Vilnius University Hospital Santaros Clinics

Vilnius, 08661, Lithuania

Location

Related Publications (2)

• De Potter T, Scherr D, Purerfellner H, Rackauskas G, Hansen J, Vijgen J, Phlips T, Knecht S, Szeplaki G, Van Herendael H, Kronborg MB, Berte B, Ruwald M, Kollias G, Lukac P, Tan T, Duytschaever M. Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results. Europace. 2025 Sep 1;27(9):euaf174. doi: 10.1093/europace/euaf174.

  PMID: 40796332 DERIVED

• Duytschaever M, Rackauskas G, De Potter T, Hansen J, Knecht S, Phlips T, Vijgen J, Scherr D, Szeplaki G, Van Herendael H, Kronborg MB, Berte B, Purerfellner H, Lukac P. Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results. Europace. 2024 May 2;26(5):euae088. doi: 10.1093/europace/euae088.

  PMID: 38696675 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Director Medical Affairs
• Organization: Biosense Webster, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 2, 2023
• Study Start: February 27, 2023
• Primary Completion: September 25, 2023
• Study Completion: June 17, 2024
• Last Updated: July 1, 2025
• Results First Posted: October 16, 2024

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (2); AU (2); BE (4); LI (1)