Status:
COMPLETED
AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation
Lead Sponsor:
Acutus Medical
Conditions:
Recurrent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 High Resolution Imaging and Mapping System ...
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 High Resolution Imaging and Mapping System ...
Eligibility Criteria
Inclusion
- Male or female eighteen (18) years of age or older
- Currently scheduled for a repeat endocardial ablation of AF where the index atrial fibrillation ablation procedure was completed ≤ twenty-four (24) months prior to enrollment and the subject has demonstrated at least one episode of post-ablation non-self-terminating AF
Exclusion
- No more than two (2) previous left-atrial ablations
- Structural heart disease or implanted cardiac devices
- History of blood clotting or bleeding disease
- Pregnant or lactating (current or anticipated during study follow up)
- Evidence of left atrial thrombus
Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2020
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03368781
Start Date
April 12 2018
End Date
October 29 2020
Last Update
July 27 2022
Active Locations (15)
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1
UZ Brussel Centrum voor Hart-en Vaatziekten
Belsele, Jette, Belgium, 1090
2
Southlake Regional Health Center
Newmarket, Ontario, Canada, L3Y 2P9
3
Na Homolce Hospital
Prague, Czechia, 150 30
4
Klinikum Coburg
Coburg, Germany, 96450