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

Acutus Medical

Status: Completed

Conditions: Persistent Atrial Fibrillation

Treatments: Device: AcQMap System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02825992

CL-AF-001 (Other Identifier)

CL-AF-002

Details and patient eligibility

About

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)

Full 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™ 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.

Enrollment: 129 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

AcQMap System

Other group

Description:

All patients who underwent catheter ablation using the AcQMap System

Treatment:

Device: AcQMap System