NCT02825992

Brief Summary

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)

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
6 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 17, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 5, 2020

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

July 5, 2016

Results QC Date

May 15, 2020

Last Update Submit

June 3, 2020

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    12 Months

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

    24 hours

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

    6, 9, and 12 Months

Study Arms (1)

AcQMap System

OTHER

All patients who underwent catheter ablation using the AcQMap System

Device: AcQMap System

Interventions

AcQMap SystemDEVICE

3D imaging and mapping system for cardiac chambers

AcQMap System

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for an ablation of persistent atrial fibrillation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Southlake Regional Health Center

Newmarket, Ontario, L3Y 2P9, Canada

Location

Na Homolce Hospital

Prague, 150 30, Czechia

Location

Vivantes Klinikum Am Urban

Berlin, 10967, Germany

Location

Herzzentrum der Universität zu Köln

Cologne, D-50937, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Centro Cardiologico Monzino

Milan, 20100, Italy

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

St. Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

Location

Freeman Hospital

Newcastle, Newcastle Upon Tyne, NE7 7DN, United Kingdom

Location

Papworth Hospital

Cambridge, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 31242746DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Identified limitations * Not an RCT limiting the comparability of the results to current SOC * A first-generation device study with limited experienced users. Outcome measures may not be reflective of current clinical results.

Results Point of Contact

Title
Steve McQuillan, Sr. Vice President Regulatory, Clinical, & Quality Assurance
Organization
Acutus Medical, Inc.
steven.mcquillan@acutus.com
763-331-4344

Study Officials

  • Stephan Willems, MD

    Universitätsklinikum Hamburg-Eppendorf (UKE)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 7, 2016

Study Start

October 17, 2016

Primary Completion

April 30, 2017

Study Completion

May 15, 2018

Last Updated

June 5, 2020

Results First Posted

June 5, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)GB(4)DE(3)CA(1)IT(1)NL(2)