Back to resultsA Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspIRE)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pulsed Field Ablation (PFA) Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF)
- Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
- Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation 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:
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Previous left atrium (LA) ablation or surgery
- Participant known to require ablation outside the PV region (example. cavotricuspid isthmus [CTI] region, 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 LA (LAD >50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))
Sites / Locations
- Medical University Graz
- Ordensklinikum Linz Elisabethinen
- OLV Aalst
- AZ Sint-Jan Brugge
- Ziekenhuis Oost-Limburg Genk Campus Sint-Jan
- Jessa Ziekenhuis - Campus Virga Jesse
- London Health Sciences Centre
- Southlake Regional Health Centre
- University Hospital Center Split
- Nemocnice na Homolce
- Centre Hospitalier Universitaire (CHU) de Bordeaux
- Ospedale Generale Regionale "F. Miulli"
- Vilnius University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Participants with Paroxysmal Atrial Fibrillation (PAF)
Arm Description
Participants with PAF and who are candidates for catheter ablation will be enrolled.
Outcomes
Primary Outcome Measures
Number of Participants with of Primary Adverse Events (PAEs)
Participants with incidence of Primary Adverse Events (PAEs) (within seven (7) days of the initial mapping and ablation procedure) will be reported. PAEs include the adverse events like Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction and pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/CVA, thromboembolism, transient Ischemic Attack (TIA)
Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL] Greater than Equal to (>=)30 Seconds Within 91-365 days post Index Procedure
Atrial arrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
Secondary Outcome Measures
Number of Participants who Achieved Acute Procedural Success
Acute procedural success defined as confirmation of entrance block in all clinically relevant targeted PVs after adenosine/ isoproterenol challenge.
Rate of Freedom from Documented Symptomatic Re-Occurrence Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) >=30 Seconds Within 91-365 days post Index Procedure
Atrial arrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in AF symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04524364
Brief Title
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
Acronym
inspIRE
Official Title
Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 23, 2020 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
May 9, 2023 (Actual)
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 primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE 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
272 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with Paroxysmal Atrial Fibrillation (PAF)
Arm Type
Other
Arm Description
Participants with PAF and who are candidates for catheter ablation will be enrolled.
Intervention Type
Device
Intervention Name(s)
Pulsed Field Ablation (PFA) Therapy
Intervention Description
Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).
Primary Outcome Measure Information:
Title
Number of Participants with of Primary Adverse Events (PAEs)
Description
Participants with incidence of Primary Adverse Events (PAEs) (within seven (7) days of the initial mapping and ablation procedure) will be reported. PAEs include the adverse events like Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction and pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/CVA, thromboembolism, transient Ischemic Attack (TIA)
Time Frame
Within one week (7 days) post-procedure
Title
Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL] Greater than Equal to (>=)30 Seconds Within 91-365 days post Index Procedure
Description
Atrial arrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
Time Frame
91-365 Days
Secondary Outcome Measure Information:
Title
Number of Participants who Achieved Acute Procedural Success
Description
Acute procedural success defined as confirmation of entrance block in all clinically relevant targeted PVs after adenosine/ isoproterenol challenge.
Time Frame
91-365 Days
Title
Rate of Freedom from Documented Symptomatic Re-Occurrence Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) >=30 Seconds Within 91-365 days post Index Procedure
Description
Atrial arrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
Time Frame
91-365 Days
Title
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score
Description
An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in AF symptoms.
Time Frame
Baseline, Month 3, 6 and 12
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)
Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced by recurrent symptomatic atrial fibrillation 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:
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
Previous left atrium (LA) ablation or surgery
Participant known to require ablation outside the PV region (example. cavotricuspid isthmus [CTI] region, 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 LA (LAD >50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))
Facility Information:
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Ordensklinikum Linz Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
OLV Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
AZ Sint-Jan Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg Genk Campus Sint-Jan
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
ZIP/Postal Code
ON L3Y 2P9
Country
Canada
Facility Name
University Hospital Center Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Nemocnice na Homolce
City
Prague
ZIP/Postal Code
150 30 District 5
Country
Czechia
Facility Name
Centre Hospitalier Universitaire (CHU) de Bordeaux
City
Bordeaux
ZIP/Postal Code
33600
Country
France
Facility Name
Ospedale Generale Regionale "F. Miulli"
City
Acquaviva delle Fonti
ZIP/Postal Code
70021
Country
Italy
Facility Name
Vilnius University Hospital
City
Vilnius
ZIP/Postal Code
8661
Country
Lithuania
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
IPD Sharing URL
http://yoda.yale.edu.
Learn more about this trial
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
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