inspIRE: A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)
Study Details
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 |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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).
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Outcome Measures
Primary Outcome Measures
- Number of Participants with of Primary Adverse Events (PAEs) [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)
- 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 [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
- Number of Participants who Achieved Acute Procedural Success [91-365 Days]
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 [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.
- Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score [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
Criteria
Inclusion Criteria:
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Diagnosed with Symptomatic paroxysmal atrial fibrillation (PAF)
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Selected for atrial fibrillation (AF) ablation procedure by pulmonary vein isolation (PVI)
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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
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Willing and capable of providing consent
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Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion Criteria:
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AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
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Previous left atrium (LA) ablation or surgery
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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)
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Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
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Severe dilatation of the LA (LAD >50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE))
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University Graz | Graz | Austria | 8036 | |
| 2 | Ordensklinikum Linz Elisabethinen | Linz | Austria | 4020 | |
| 3 | OLV Aalst | Aalst | Belgium | 9300 | |
| 4 | AZ Sint-Jan Brugge | Brugge | Belgium | 8000 | |
| 5 | Ziekenhuis Oost-Limburg Genk Campus Sint-Jan | Genk | Belgium | 3600 | |
| 6 | Jessa Ziekenhuis - Campus Virga Jesse | Hasselt | Belgium | 3500 | |
| 7 | London Health Sciences Centre | London | Ontario | Canada | N6A 5A5 |
| 8 | Southlake Regional Health Centre | Newmarket | Canada | ON L3Y 2P9 | |
| 9 | University Hospital Center Split | Split | Croatia | 21000 | |
| 10 | Nemocnice na Homolce | Prague | Czechia | 150 30 District 5 | |
| 11 | Centre Hospitalier Universitaire (CHU) de Bordeaux | Bordeaux | France | 33600 | |
| 12 | Ospedale Generale Regionale "F. Miulli" | Acquaviva delle Fonti | Italy | 70021 | |
| 13 | Vilnius University Hospital | Vilnius | Lithuania | 8661 |
Sponsors and Collaborators
- Biosense Webster, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BWI_2019_08
- BWI_2019_08