RECOVER AF

ClinicalTrials.gov Identifier: NCT03368781

Full Title

Utilizing Novel Dipole Density Capabilities to Objectively
Visualize the Etiology of Recurrent Atrial Fibrillation
Following a Failed AF Ablation
(RECOVER AF)

Sponsor: Acutus Medical®, Inc.

Condition:
Recurrent Atrial Fibrillation

Interventional Clinical Trial
Treatments:
Device: AcQMap® High Resolution Imaging and Mapping System

Purpose
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. The patient population includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-004 [EU])

A prospective, single-arm, multi-center, multi-national, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. The patient population includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-005 [Canada])

More information via
NIHR Website
clinicaltrials.gov