FOCALFLEX
Research type
Research Study
Full title
A study of FOCAL pulsed field ablation with the TactiFLEX SE Catheter and Volt Generator for the treatment of paroxysmal atrial fibrillation
IRAS ID
341283
Contact name
Alessandra Denaro
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
This clinical investigation is intended to demonstrate safety and effectiveness of the TactiFlex™ Ablation Catheter Sensor Enabled™, the Volt™ PFA Generator, and EnSite™ X EP System with EnSite™ Pulsed Field Ablation Software (for simplicity of reference this device collection will hereafter be referred to as the TactiFlex PFA system) for the treatment of symptomatic, recurrent paroxysmal atrial fibrillation. This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical investigation. Up to 150 subjects will be enrolled in this clinical investigation at up to 25 investigational sites worldwide. The clinical investigation is sponsored by Abbott.
This clinical investigation will be conducted in accordance with this Clinical Investigational Plan. All investigators involved in the conduct of the clinical investigation will be qualified by education, training, or experience to perform their tasks and this training will be documented appropriately.REC name
HSC REC B
REC reference
24/NI/0074
Date of REC Opinion
24 Jul 2024
REC opinion
Further Information Favourable Opinion