AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation
- Conditions
- Recurrent Atrial Fibrillation
- Interventions
- Device: AcQMap Imaging and Mapping System
- Registration Number
- NCT03368781
- Lead Sponsor
- Acutus Medical
- Brief Summary
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 \[Canada\])
- Detailed Description
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 \[Canada\])
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AcQMap Imaging and Mapping AcQMap Imaging and Mapping System 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets 12 hours 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
- Secondary Outcome Measures
Name Time Method Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure 6 months 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 4 hours Documentation of procedure data including total time
Procedure Performance: Total Fluoroscopy Time 4 hours Documentation of procedure data including fluoroscopy time
Procedure Performance: Ablation Times for PVI 2 hours Documentation of procedure data including ablation times for PVI
Procedure Performance: Ablation Times for Non-PV Targets 2 hours Documentation of procedure data including ablation times for non-PV targets
Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure 12 months 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
Trial Locations
- Locations (14)
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Southlake Regional Health Center
🇨🇦Newmarket, Ontario, Canada
Na Homolce Hospital
🇨🇿Prague, Czechia
Erasmus MC
🇳🇱Rotterdam, Netherlands
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
Sheffield Teaching Hospital Northern
🇬🇧Sheffield, United Kingdom
Klinikum Coburg
🇩🇪Coburg, Germany
UZ Brussel Centrum voor Hart-en Vaatziekten
🇧🇪Belsele, Jette, Belgium
Herzzentrum der Universität zu Köln
🇩🇪Cologne, Germany
Papworth Hospital NHS
🇬🇧Cambridge, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom