Trials / Completed
CompletedNCT02825992
Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation
Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Acutus Medical · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AcQMap System | 3D imaging and mapping system for cardiac chambers |
Timeline
- Start date
- 2016-10-17
- Primary completion
- 2017-04-30
- Completion
- 2018-05-15
- First posted
- 2016-07-07
- Last updated
- 2020-06-05
- Results posted
- 2020-06-05
Locations
12 sites across 6 countries: Canada, Czechia, Germany, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT02825992. Inclusion in this directory is not an endorsement.