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

Persistent Atrial Fibrillation Clinical Trial

— UNCOVER-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825992
• Other study ID #: CL-AF-002
• Secondary ID: CL-AF-001
• Status: Completed
• Phase: N/A
• Start date: October 17, 2016
• Est. completion date: May 15, 2018

Study information

• Verified date: June 2020
• Source: Acutus Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Other known NCT identifiers

• NCT02462980

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: May 15, 2018
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• AcQMap System
3D imaging and mapping system for cardiac chambers

Locations

Country	Name	City	State
Canada	Southlake Regional Health Center	Newmarket	Ontario
Czechia	Na Homolce Hospital	Prague
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Herzzentrum der Universität zu Köln	Cologne
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Italy	Centro Cardiologico Monzino	Milano
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	St. Antonius Hospital	Nieuwegein
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Royal Brompton Hospital	London
United Kingdom	Freeman Hospital	Newcastle	Newcastle Upon Tyne
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Acutus Medical

Countries where clinical trial is conducted

Canada,  Czechia,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Who Experienced at Least One Adverse Events.	Recording of all adverse events through 12 month follow-up	12 Months
Secondary	Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure.	Conversion to sinus rhythm post ablation	24 hours
Secondary	Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation.	Freedom from AF	6, 9, and 12 Months