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

• ClinicalTrials.gov Identifier: NCT04524364
• Recruitment Status: Completed
• First Posted: August 24, 2020
• Last Update Posted: June 29, 2023
• Sponsor: Biosense Webster, Inc.
• Information provided by (Responsible Party): Biosense Webster, Inc.

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).

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation	Device: Pulsed Field Ablation (PFA) Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 272 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)
• Actual Study Start Date: August 23, 2020
• Actual Primary Completion Date: May 9, 2023
• Actual Study Completion Date: May 9, 2023

Arms and Interventions

Arm

Intervention/treatment

Participants with Paroxysmal Atrial Fibrillation (PAF); Participants with PAF and who are candidates for catheter ablation will be enrolled.

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).

Outcome Measures

Primary Outcome Measures :

1. Number of Participants with of Primary Adverse Events (PAEs) [ Time Frame: Within one week (7 days) post-procedure ]
   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)
2. 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 [ Time Frame: 91-365 Days ]
   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 :

1. Number of Participants who Achieved Acute Procedural Success [ Time Frame: 91-365 Days ]
   Acute procedural success defined as confirmation of entrance block in all clinically relevant targeted PVs after adenosine/ isoproterenol challenge.
2. 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 [ Time Frame: 91-365 Days ]
   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.
3. Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score [ Time Frame: Baseline, Month 3, 6 and 12 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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))

Contacts and Locations

Locations

Austria

Medical University Graz

Graz, Austria, 8036

Ordensklinikum Linz Elisabethinen

Linz, Austria, 4020

Belgium

OLV Aalst

Aalst, Belgium, 9300

AZ Sint-Jan Brugge

Brugge, Belgium, 8000

Ziekenhuis Oost-Limburg Genk Campus Sint-Jan

Genk, Belgium, 3600

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Belgium, 3500

Canada, Ontario

London Health Sciences Centre

London, Ontario, Canada, N6A 5A5

Canada

Southlake Regional Health Centre

Newmarket, Canada, ON L3Y 2P9

Croatia

University Hospital Center Split

Split, Croatia, 21000

Czechia

Nemocnice na Homolce

Prague, Czechia, 150 30 District 5

France

Centre Hospitalier Universitaire (CHU) de Bordeaux

Bordeaux, France, 33600

Italy

Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, Italy, 70021

Lithuania

Vilnius University Hospital

Vilnius, Lithuania, 8661

Sponsors and Collaborators

Biosense Webster, Inc.

More Information

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT04524364
• Other Study ID Numbers: BWI_2019_08; BWI_2019_08 ( Other Identifier: Biosense Webster, Inc. )
• First Posted: August 24, 2020
• Last Update Posted: June 29, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: http://yoda.yale.edu.

• 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

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes