A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)

Atrial Fibrillation Clinical Trial

— inspIRE  

Official title:

Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524364
• Other study ID #: BWI_2019_08
• Secondary ID: BWI_2019_08
• Status: Completed
• Phase: N/A
• Start date: August 23, 2020
• Est. completion date: May 9, 2023

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: May 9, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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))

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Pulsed Field Ablation (PFA) Therapy
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).

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Austria	Ordensklinikum Linz Elisabethinen	Linz
Belgium	OLV Aalst	Aalst
Belgium	AZ Sint-Jan Brugge	Brugge
Belgium	Ziekenhuis Oost-Limburg Genk Campus Sint-Jan	Genk
Belgium	Jessa Ziekenhuis - Campus Virga Jesse	Hasselt
Canada	London Health Sciences Centre	London	Ontario
Canada	Southlake Regional Health Centre	Newmarket
Croatia	University Hospital Center Split	Split
Czechia	Nemocnice na Homolce	Prague
France	Centre Hospitalier Universitaire (CHU) de Bordeaux	Bordeaux
Italy	Ospedale Generale Regionale "F. Miulli"	Acquaviva delle Fonti
Lithuania	Vilnius University Hospital	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Croatia,  Czechia,  France,  Italy,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Primary Adverse Events (PAEs)	An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. The primary safety endpoint was the incidence of PAEs (within 7 days of the initial mapping and ablation procedure). PAEs included the following AEs: Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction, pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/cerebrovascular accident (CVA), thromboembolism, and transient ischemic attack (TIA).	Within 7 days post-procedure on Day 0
Primary	Kaplan-Meier Estimates of the Success Rate of Freedom From Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure	Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented (symptomatic and asymptomatic) atrial arrhythmia (AF, AT, or AFL) recurrence based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.	From Day 91 up to Day 365 post index procedure on Day 0
Secondary	Number of Participants Who Achieved Acute Procedural Success	Number of participants who achieved acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all clinically relevant targeted pulmonary veins (PVs) after adenosine/ isoproterenol challenge.	Day 0 (Day of procedure)
Secondary	Kaplan-Meier Estimates of the Success Rate of Freedom From Documented Symptomatic Re-Occurrence of Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) Episodes From Day 91 to Day 365 Post Index Procedure	Kaplan-Meier estimates of the success rate of freedom from primary effectiveness failure, that is, documented symptomatic re-occurrence of atrial arrhythmia (AF, AT, or AFL) episodes based on electrocardiographic data (>=30 seconds on arrhythmia monitoring device) from Day 91 to Day 365 post index procedure, was reported. Acute procedural failure defined as failure to confirm entrance block in all PVs except those that are silent and/or cannot be cannulated post-procedure, use of a non-study catheter for PV isolation, or failure to have PFA delivery with the study catheter due to IRE system malfunctions, was also considered a long-term effectiveness failure.	From Day 91 up to Day 365 post index procedure on Day 0
Secondary	Change From Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score	Change from baseline in AFEQT total score was reported. The AFEQT questionnaire is an atrial fibrillation-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of atrial fibrillation on participants' HRQoL. The questionnaire includes 20 questions on a 7-point Likert scale. Questions 1-18 evaluate HRQoL and questions 19-20 relate to participants' satisfaction with treatment. Overall or subscale scores range from 0 to 100, where 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 QoL. Total score was calculated using AFEQT formula: 100 -([sum of severity for all questions answered - number of questions answered]*100 / total number questions answered*6).	Baseline, Months 3, 6, and 12