Clinical trial NCT02825992: Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation
Official title: Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)
timeFrame: 24 hours
Secondary outcomes:
measure: Number of Participants Who Experienced at Least One Adverse Events.
timeFrame: 12 Months
measure: Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure.
timeFrame: 24 hours
measure: Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation.
timeFrame: 6, 9, and 12 Months
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Center
state: Ontario
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Cologne
country: Germany
facility: Herzzentrum der Universität zu Köln
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
state: Newcastle Upon Tyne
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf (UKE)
name: Stephan Willems, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.