N/A
N=128
AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation
Recurrent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03368781 ↗Enrolled (actual)
128
Serious AEs
7.8%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets — 99 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AcQMap Imaging and Mapping System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acutus Medical
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets |
99 | — |
| SECONDARY Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure |
85 | — |
| SECONDARY Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out |
3.3 | — |
| SECONDARY Procedure Performance: Total Fluoroscopy Time |
25.6 | — |
| SECONDARY Procedure Performance: Ablation Times for PVI |
8.5 | — |
| SECONDARY Procedure Performance: Ablation Times for Non-PV Targets |
26.2 | — |
| SECONDARY Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure |
78 | — |
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 during an atrial fibrillation retreatment ablation procedure. (CLP-AF-004 [EU])
A prospective, single-arm, multi-center, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. (CLP-AF-005 [Canada])
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03368781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.