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

Primary Purpose

Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
Sponsored by
Biosense Webster, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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])

Sites / Locations

  • Medical University Graz
  • Ordensklinikum Linz GmbH Elisabethinen
  • O.L.V. Ziekenhuis
  • AZ Sint-Jan
  • Ziekenhuis Oost-Limburg
  • Jessa Ziekenhuis
  • Aarhus University Hospital
  • Gentofte Hospital
  • Odense University Hospital
  • Vilnius University Hospital Santaros Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 22, 2023
Last Updated
October 10, 2023
Sponsor
Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05752487
Brief Title
A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator
Acronym
SmartfIRE
Official Title
Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
September 25, 2023 (Actual)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants with Incidence of Primary Adverse Events (PAE's)
Description
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.
Time Frame
Within 7 days post-procedure
Title
Percentage of Participants with Acute Procedural Success
Description
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.
Time Frame
Immediate post-procedure
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Within day 91 to day 365 post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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])
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biosense Webster, Inc. Clinical Trial
Organizational Affiliation
Biosense Webster, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
O.L.V. Ziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Vilnius University Hospital Santaros Clinics
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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