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

Study Overview
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Brief Summary
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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
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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])

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

Conditions
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Recurrent Atrial Fibrillation

Intervention / Treatment
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* Device: AcQMap Imaging and Mapping System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: None randomized, single-arm, open label.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AcQMap Imaging and Mapping<br>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. | Device: AcQMap Imaging and Mapping System<br>* 3D Cardiac Imaging and Mapping during ablation procedures<br>* Other names: AcQMap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out | Documentation of procedure data including total time | 4 hours | 
| Procedure Performance: Total Fluoroscopy Time | Documentation of procedure data including fluoroscopy time | 4 hours | 
| Procedure Performance: Ablation Times for PVI | Documentation of procedure data including ablation times for PVI | 2 hours | 
| Procedure Performance: Ablation Times for Non-PV Targets | Documentation of procedure data including ablation times for non-PV targets | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation