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 \[Canada\])
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
128
3D Cardiac Imaging and Mapping during ablation procedures
UZ Brussel Centrum voor Hart-en Vaatziekten
Belsele, Jette, Belgium
Southlake Regional Health Center
Newmarket, Ontario, Canada
Na Homolce Hospital
Prague, Czechia
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
Time frame: 12 hours
Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure
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
Time frame: 6 months
Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out
Documentation of procedure data including total time
Time frame: 4 hours
Procedure Performance: Total Fluoroscopy Time
Documentation of procedure data including fluoroscopy time
Time frame: 4 hours
Procedure Performance: Ablation Times for PVI
Documentation of procedure data including ablation times for PVI
Time frame: 2 hours
Procedure Performance: Ablation Times for Non-PV Targets
Documentation of procedure data including ablation times for non-PV targets
Time frame: 2 hours
Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure
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
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Klinikum Coburg
Coburg, Germany
Klinikum Coburg
Coburg, Germany
Herzzentrum der Universität zu Köln
Cologne, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
St. Antonius Hospital
Nieuwegein, Netherlands
Erasmus MC
Rotterdam, Netherlands
Papworth Hospital NHS
Cambridge, United Kingdom
...and 5 more locations
Time frame: 12 months