AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation (RECOVER AF)

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

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. (CLP-AF-004 [EU]) A prospective, single-arm, multi-center, 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. (CLP-AF-005 [Canada])

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])

Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation.

Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets

At the procedure conclusion, confirmation of electrical isolation of all pulmonary veins and elimination/modification of all non-PV targets as identified by the AcQMap System

Recording of all subjects who are atrial fibrillation free from events lasting > 30 seconds at 6-months as measured by a 48-hour continuous ECG

Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out

Recording of all subjects who are atrial fibrillation free from events lasting > 30 seconds at 12-months as measured by a 48-hour continuous ECG

Inclusion Criteria: Male or female eighteen (18) years of age or older Currently scheduled for a repeat endocardial ablation of AF where the index atrial fibrillation ablation procedure was completed ≤ twenty-four (24) months prior to enrollment and the subject has demonstrated at least one episode of post-ablation non-self-terminating AF Exclusion Criteria: No more than two (2) previous left-atrial ablations Structural heart disease or implanted cardiac devices History of blood clotting or bleeding disease Pregnant or lactating (current or anticipated during study follow up) Evidence of left atrial thrombus