Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- Device: AcQMap System
- Registration Number
- NCT02825992
- Lead Sponsor
- Acutus Medical
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- Scheduled for an ablation of persistent atrial fibrillation
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AcQMap System AcQMap System All patients who underwent catheter ablation using the AcQMap System
- Primary Outcome Measures
Name Time Method Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) 24 hours MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. 6, 9, and 12 Months Freedom from AF
Number of Participants Who Experienced at Least One Adverse Events. 12 Months Recording of all adverse events through 12 month follow-up
Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. 24 hours Conversion to sinus rhythm post ablation
Trial Locations
- Locations (12)
Southlake Regional Health Center
🇨🇦Newmarket, Ontario, Canada
Na Homolce Hospital
🇨🇿Prague, Czechia
Centro Cardiologico Monzino
🇮🇹Milano, Italy
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Papworth Hospital
🇬🇧Cambridge, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Freeman Hospital
🇬🇧Newcastle, Newcastle Upon Tyne, United Kingdom
Vivantes Klinikum Am Urban
🇩🇪Berlin, Germany
Herzzentrum der Universität zu Köln
🇩🇪Cologne, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Royal Brompton Hospital
🇬🇧London, United Kingdom