PFA and PFCA for PsAF (CS-169 Revision B)
Research type
Research Study
Full title
Adagio Medical Pulsed Field Ablation (PFA) and Pulsed Field CryoAblation (PFCA™) Systems for Persistent Atrial Fibrillation (PsAF)
IRAS ID
318563
Contact name
Mark Gallagher
Contact email
Sponsor organisation
Adagio Medical Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
This clinical study is intended to evaluate the safety and performance of the investigational medical devices, the Pulsed Field Ablation (PFA) and Pulsed Field CryoAblation (PFCA) Systems for the treatment of persistent atrial fibrillation.
- The Pulsed Field Ablation (PFA) System is a new technology that uses electric field pulses to perform ablation.
- The Pulsed Field CryoAblation (PFCA) System is a new technology that uses very low temperatures, generated by ultra-cold nitrogen circulating inside the PFCA catheter, and electric field pulses to perform ablation.This trial will include approx 78 participants worldwide.
- This trial is first-in-human (FIH) and randomized study to collect data on safety and performance of the PFA and PFCA Systems. First-in-human means you are one of the first patients to be treated with the IMDs. Participants will be randomly selected for ablation by either the Adagio PFA or PFCA System. A draw will decide which System a participant are given.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0027
Date of REC Opinion
6 Mar 2023
REC opinion
Further Information Favourable Opinion