Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation

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™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU) A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)

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™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU) A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian) The research study was conducted in the EU and Canada. The protocol and the corresponding NCT number is as follows: NCT02462980 (Protocol CL-AF-001, Site Ontario, Canada Dr. Verma = PI) The above record was combined into one as both protocols are essentially identical (one is post market [EU] and the other pre-market [Canada] and one study report will be written that encompasses the data/results for both protocols.

Official Title
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Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: AcQMap System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for an ablation of persistent atrial fibrillation Exclusion Criteria: Any duration of continuous AF lasting longer than 12 months Previous AF ablation Significant structural heart disease Previous cerebral infarct Major bleeding disorders Pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AcQMap System<br>All patients who underwent catheter ablation using the AcQMap System | Device: AcQMap System<br>* 3D imaging and mapping system for cardiac chambers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) | MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced at Least One Adverse Events. | Recording of all adverse events through 12 month follow-up | 12 Months | 
| Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. | Conversion to sinus rhythm post ablation | 24 hours | 
| Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. | Freedom from AF | 6, 9, and 12 Months |