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

Acutus Medical129 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

129

Conditions

Persistent Atrial Fibrillation

Interventions

AcQMap SystemDEVICE

3D imaging and mapping system for cardiac chambers

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (12)

Southlake Regional Health Center

Newmarket, Ontario, Canada

Na Homolce Hospital

Prague, Czechia

Vivantes Klinikum Am Urban

Berlin, Germany

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Secondary Outcomes

Number of Participants Who Experienced at Least One Adverse Events.

Recording of all adverse events through 12 month follow-up

Time frame: 12 Months

Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure.

Conversion to sinus rhythm post ablation

Time frame: 24 hours

Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation.

Freedom from AF

Time frame: 6, 9, and 12 Months

Data from ClinicalTrials.gov

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