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

Primary Purpose

Persistent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AcQMap System
Sponsored by
Acutus Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Southlake Regional Health Center
  • Na Homolce Hospital
  • Vivantes Klinikum Am Urban
  • Herzzentrum der Universität zu Köln
  • Universitätsklinikum Hamburg-Eppendorf
  • Centro Cardiologico Monzino
  • Maastricht University Medical Center
  • St. Antonius Hospital
  • Freeman Hospital
  • Papworth Hospital
  • Royal Brompton Hospital
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AcQMap System

Arm Description

All patients who underwent catheter ablation using the AcQMap System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Who Experienced at Least One Adverse Events.
Recording of all adverse events through 12 month follow-up
Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure.
Conversion to sinus rhythm post ablation
Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation.
Freedom from AF

Full Information

First Posted
July 5, 2016
Last Updated
June 3, 2020
Sponsor
Acutus Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02825992
Brief Title
Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation
Acronym
UNCOVER-AF
Official Title
Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 17, 2016 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acutus Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AcQMap System
Arm Type
Other
Arm Description
All patients who underwent catheter ablation using the AcQMap System
Intervention Type
Device
Intervention Name(s)
AcQMap System
Intervention Description
3D imaging and mapping system for cardiac chambers
Primary Outcome Measure Information:
Title
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)
Description
MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of Participants Who Experienced at Least One Adverse Events.
Description
Recording of all adverse events through 12 month follow-up
Time Frame
12 Months
Title
Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure.
Description
Conversion to sinus rhythm post ablation
Time Frame
24 hours
Title
Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation.
Description
Freedom from AF
Time Frame
6, 9, and 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Willems, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf (UKE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southlake Regional Health Center
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
150 30
Country
Czechia
Facility Name
Vivantes Klinikum Am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Herzzentrum der Universität zu Köln
City
Cologne
ZIP/Postal Code
D-50937
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Centro Cardiologico Monzino
City
Milano
ZIP/Postal Code
20100
Country
Italy
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Freeman Hospital
City
Newcastle
State/Province
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Papworth Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31242746
Citation
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.
Results Reference
derived

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

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