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COMPLETED
NCT05408754
NA

Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation

Sponsor: Adagio Medical

View on ClinicalTrials.gov

Summary

A prospective, two-arm, multi-center, randomized, open-label, pre-market, First-in-Human clinical study designed to provide safety and performance data regarding the use of the Adagio PFA and PFCA Systems in the treatment of PsAF.

Official title: PARALELL - Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

89

Start Date

2022-10-20

Completion Date

2025-03-03

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

DEVICE

Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF.

Treatment will include the isolation of pulmonary veins (PVIs), and isolation of the left atrial posterior wall (PWI). A right atrial cavo-tricuspid line for bi-directional block may be performed at discretion and clinical judgment of the investigator

Locations (6)

Onze-Lieve-Vrouwziekenhuis (OLV)

Aalst, Belgium

McGill University Health Centre (MUHC), Montreal General Hospital (MGH)

Montreal, Quebec, Canada

Nemocnice Na Homolce

Prague, Czechia

Blackrock Health

Dublin, Ireland

St Antonius Ziekenhuis

Nieuwegein, Netherlands

St George'S University Hospital

London, United Kingdom