Skip to main content
OpenTrials
Completed

NCT Number: NCT02825992

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southlake Regional Health Center, Newmarket, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AcQMap System

Device

3D imaging and mapping system for cardiac chambers

Primary outcomes

  1. Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)

    Time frame: 24 hours

    MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.

Secondary outcomes

  1. Number of Participants Who Experienced at Least One Adverse Events.

    Time frame: 12 Months

    Recording of all adverse events through 12 month follow-up

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

    Time frame: 24 hours

    Conversion to sinus rhythm post ablation

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

    Time frame: 6, 9, and 12 Months

    Freedom from AF

Sponsors and collaborators

Lead sponsor

Acutus Medical

Industry

Registry information

Official study title

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

Acronym: UNCOVER-AF

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 7, 2016
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.