Learn More About the inspIRE Trial
Learn More About Radiofrequency/PFA Dual Energy Research​
Learn More About Large-Tip Focal PFA Energy Research

inspIRE1

is a prospective, multicenter, single-arm interventional study for the VARIPULSE™ Platform.​

Icon of building with door and nine windows

The study included 13 EMEA & Canada centers.​

Icon of patient drawing attention to their heart indicating arrhythmia

226 patients with symptomatic paroxysmal AF were enrolled in the study.

83 participants from Wave II reached 12-month follow-up.

The Primary Safety and Effectiveness Endpoints Were Met

The inspIRE trial achieved both primary safety and efficacy endpoints during a prespecified interim analysis.

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Primary Adverse Event Ratea

No primary adverse events were recorded in the study (14% performance goal).

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Primary Effectiveness Rateb

71% of participants met the primary effectiveness endpoint of 12-month freedom from documented AF/AFL/AT recurrence (50% performance goal).

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Clinical Success​

The estimated 12-freedom from documented AF/AFL/AT recurrence was 79%.

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Freedom From Repeat Ablation​

The estimated 12-freedom from repeat ablation was 92%.

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  1. Primary adverse events within 7 days of initial ablation, included pericarditis, myocardial infarction, cardiac tamponade/perforation, thromboembolism, stroke or cerebrovascular accident, transient ischemic attack, phrenic nerve paralysis, or major vascular access complication/bleeding, as well as death, PV stenosis, and atrioesophageal fistula that occurred later than 7 days post-procedure. All safety events were adjudicated by an independent clinical endpoint committee​
  2. The 12-month effectiveness is based on the 83 participants that completed 12-month follow-up at the time of the prespecified interim analysis.​
     

Ablation Workflow​

CARTO image displaying a preablation voltage map

Preablation LA Map

Voltage map performed per standard-of-care.

Image of two physicians working on ablation case

PVI Ablationc

CARTO image displaying a postablation voltage map

Map After Adenosine/Isoproterenol Challenge

(No waiting period)​

  1. Ablation recommendation: at least 12 applications per PV (translates to 48 applications per participant).​​
Figures adapted from Duytschaever M, et al. Circ Arrhythm Electrophysiol. 2023;16(3):e011780 under the CC BY license.
 


Patient Eligibility Criteria

Key Inclusion Criteria

  • 18–75 years old 
  • Diagnosed with symptomatic paroxysmal AF
  • Selected for AF ablation procedure by PVI
  • Failed/intolerance to ≥1 Class I–IV AADs

Key Exclusion Criteria

  • AF secondary to reversible or noncardiac cause
  • Previous surgical or catheter ablation for AF
  • Anticipation of receiving ablation other than PVI
  • Persistent AF

Follow-Up​

Months 1, 3, 6, and 12​

Stringent Monitoring​

  • Remote arrhythmia monitoring: weekly between Months 3–5, monthly between Months 6–12, when symptomatic​
  • 24-hour Holter: Months 3, 6, 12
  • ECG: Standard of cared

n=40​

Wave 1
Safety characterization, post-PFA EGD

n=186​

Wave 2
Safety and effectiveness up to 12 months

  1. ECG was conducted per each site’s standard-of-care practice; it was not mandated by the protocol to be completed on every visit.​
     

inspIRE Deep Sedation Protocol Case Study - Complications and Pain Tolerance2

This single-center analysis showed that ablation procedures with the variable loop catheter can be safely and efficiently performed by experienced operators without general anesthesia.

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Procedural Complications​

No procedural complications, muscular fasciculations or coughing were reported in the study.​

Bar graph with responses from 29 participants showing 79% very satisfied with pain management, 69% do not remember having pain during procedure, and 86% would opt for same treatment again for pain management​

Participants’ Comfort and Satisfaction​

Participants reported high levels of satisfaction with pain management during the procedure.

Read the Article​

VARIPULSE™ Catheter Preclinical Data​

Histological picture showing no thermal injury with pulsed field ablation

Preclinical Dose-Response Lesion Relationship3

Comprehensive dose–response study of pulsed field ablation using a circular catheter compared with radiofrequency ablation for pulmonary vein isolation: a preclinical study​

Hsu JC, et al. Heart Rhythm O2.2023:4(10):662-667.​

In vivo porcine model of the dose-response relationship of the lesions formed with  VARIPULSE™ Catheter compared to THERMOCOOL SMARTTOUCH™ SF Catheter. ​

Figure adapted from Hsu JC, et al. Heart Rhythm O2. Published online September 18, 2023. doi: 10.1016/j.hroo.2023.09.005 under the CC-BY license (creativecommons.org/licenses/by/4.0/).

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cellular level porcine cardiomyocytes 28 days after pulsed field ablation application

Preclinical Experience of PFA Lesion Development2

Time course of irreversible electroporation lesion development through short- and long-term follow-up in pulsed-field ablation–treated hearts.​

Grimaldi M, et at al. Circ Arrhythm Electrophysiol. 2022;15(7):e010661. ​

Preclinical study of the VARIPULSE™ Catheter showing the feasibility, safety, tissue selectivity, and durability of lesions 7- and 28-days post-PFA ablation.

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Electroanatomic voltage map of a porcine atrium 30 days after pulsed field ablation application​

Preclinical Experience of Tissue Selectivity Using the PFA Catheter3

In vivo porcine characterization of atrial lesion, safety, and efficacy utilizing a circular pulsed‐field ablation catheter including assessment of collateral damage to adjacent tissue in supratherapeutic ablation applications.​

Hsu JC, et al. J Cardiovasc Electrophysiol. 2022;33(7):1480-1488. ​

Preclinical experience using the VARIPULSE™ Catheter demonstrating tissue selectivity of PFA lesions with no esophageal damage or PV narrowing.​

Figure adapted from Hsu JC, et al. J Cardiovasc Electrophysiol. 2022;33(7):1480-1488 under the CC BY license (creativecommons.org/licenses/by/4.0/).

Read the Article
Electroanatomic voltage map of a porcine atrium 30 days after pulsed field ablation application​

Preclinical Experience of PFA Lesion Durability and Safety4

Circular multielectrode pulsed field ablation catheter lasso pulsed field ablation lesion characteristics, durability, and effect on neighboring structures

Yavin H, et al. Circ Arrhythm Electrophysiol. 2021;14(2):e009229.​

Preclinical study showing durable lesions with minimal effects on the esophagus and phrenic nerve using the VARIPULSE™ Catheter.

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PFA Catheter Platform Ongoing Studies​

admIRE trial overview, with inclusion of patients 18-75 years old, study type of registration trial, located in the United States across 30 sites​

admIRE Study

Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (admIRE)​

Design and objective: Prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the BWI IRE ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator in conjunction with the CARTO™ 3 System) when used for isolation of pulmonary veins in treatment of participants with drug refractory paroxysmal atrial fibrillation.​

The VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory bodies in any market.

Learn More About admIRE​
inspIRE trial overview, with inclusion of patients 18-75 years old, study type of registration trial, located in the EMEA and Canada regions across 13 sites​

inspIRE Trial​

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

Design and objective: Prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the IRE system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins in treatment of participants with paroxysmal atrial fibrillation.​

The VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory bodies in any market.

Learn More About inspIRE​
afIRE trial overview, with inclusion of patients 18-75 years old, study type of registration trial, located in China across 6 sites​

afIRE Study​

A Study of Multi-Electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (afIRE)​

Design and objective: Prospective, multicenter, single-arm study to demonstrate the safety and long-term effectiveness of the BWI IRE ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator in conjunction with the CARTO™ 3 System) when used for isolation of pulmonary veins in treatment of participants with drug refractory paroxysmal atrial fibrillation.​

The VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory bodies in any market.

Learn More About afIRE​