Utilizing Novel dipole density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)

Utilizing Novel dipole density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF) - UNCOVER-AF (CL-AF-002) 3694/0001

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42868

Enrollment

Registered

2017-02-02

Start date

2017-02-21

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation cardiac arrhythmia

Interventions

AcQMap

atrial fibrillation

electrophysiology

Mapping

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Scheduled for an ablation of persistent atrial fibrillation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary measurable objective is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur within the first 24 hours post-procedure. MAEs include any of the following: - Death - Cardiac perforation/tamponade - Cerebral infarct, transient ischemic attack (TIA), or systemic embolism - Major bleeding - Mitral or tricuspid valvular damage - Other serious adverse device effects (SADEs) adjudicated by an independent Clinical Events Committee (CEC) as probably related to the AcQMap System	—

Measure

Time frame

The primary measurable objective is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur within the first 24 hours post-procedure. MAEs include any of the following: - Death - Cardiac perforation/tamponade - Cerebral infarct, transient ischemic attack (TIA), or systemic embolism - Major bleeding - Mitral or tricuspid valvular damage - Other serious adverse device effects (SADEs) adjudicated by an independent Clinical Events Committee (CEC) as *probably related* to the AcQMap System

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Secondary

Measure	Time frame
Secondary measurable objectives include the following: Safety Outcome Measure - Recording and analysis of all identified adverse events (AEs) and adverse device effects (ADEs) through 12 months post-procedure. Events will be adjudicated by an independent Clinical Events Committee (CEC) for severity and relationship to the AcQMap. Procedure Outcome Measure - Analysis of the proportion of subjects with acute procedural (ablation) success defined as: Conversion to sinus rhythm (with or without DCCV) within 12 hours of the procedure OR procedural conversion to atrial flutter, atrial tachycardia or other organized supraventricular rhythm - Procedure fluoroscopy time - Ablation time to complete PVI - Ablation time for non-PVI ablation - Ablation time for right atrial ablation - Number of DCCV completed during the procedure	—

Measure

Time frame

Secondary measurable objectives include the following: Safety Outcome Measure - Recording and analysis of all identified adverse events (AEs) and adverse device effects (ADEs) through 12 months post-procedure. Events will be adjudicated by an independent Clinical Events Committee (CEC) for severity and relationship to the AcQMap. Procedure Outcome Measure - Analysis of the proportion of subjects with acute procedural (ablation) success defined as: Conversion to sinus rhythm (with or without DCCV) within 12 hours of the procedure OR procedural conversion to atrial flutter, atrial tachycardia or other organized supraventricular rhythm - Procedure fluoroscopy time - Ablation time to complete PVI - Ablation time for non-PVI ablation - Ablation time for right atrial ablation - Number of DCCV completed during the procedure

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Countries

Germany, Netherlands, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)