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)

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)

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: AcQMap System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Southlake Regional Health Center
• Czechia
  • Prague, Czechia, 150 30
    • Na Homolce Hospital
• Germany
  • Berlin, Germany, 10967
    • Vivantes Klinikum am Urban
  • Cologne, Germany, D-50937
    • Herzzentrum der Universität zu Köln
  • Hamburg, Germany
    • Universitatsklinikum Hamburg-Eppendorf
• Italy
  • Milano, Italy, 20100
    • Centro Cardiologico Monzino
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Hospital
• United Kingdom
  • Cambridge, United Kingdom
    • Papworth Hospital
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital
  • Newcastle Upon Tyne
    • Newcastle, Newcastle Upon Tyne, United Kingdom, NE7 7DN
      • Freeman Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: AcQMap System; All patients who underwent catheter ablation using the AcQMap System	Device: AcQMap System; 3D imaging and mapping system for cardiac chambers

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Acutus Medical
• Investigators: Principal Investigator: Stephan Willems, MD, Universitätsklinikum Hamburg-Eppendorf (UKE)

Publications and helpful links

General Publications

• Willems S, Verma A, Betts TR, Murray S, Neuzil P, Ince H, Steven D, Sultan A, Heck PM, Hall MC, Tondo C, Pison L, Wong T, Boersma LV, Meyer C, Grace A. Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping: UNCOVER AF Trial. Circ Arrhythm Electrophysiol. 2019 Jul;12(7):e007233. doi: 10.1161/CIRCEP.119.007233. Epub 2019 Jun 27.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2016
• Primary Completion (ACTUAL): April 30, 2017
• Study Completion (ACTUAL): May 15, 2018

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (ESTIMATE): July 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CL-AF-002; CL-AF-001 (OTHER: Acutus Medical)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No