Persistent Atrial Fibrillation
Conditions
Interventions
None listed
Sponsors
Ablacon, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Suitable candidate for intra-cardiac mapping and ablation of arrhythmias 2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law 3. Subjects with a history of documented symptomatic, persistent or longstanding persistent atrial fibrillation
Exclusion criteria
Exclusion criteria: 1. LA diameter > 5.5 cm. 2. Left ventricular ejection fraction (LVEF)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint events for this trial to assess the safety and effectiveness of the Ablamap® Software System to guide therapy for the treatment of persistent atrial fibrillation are as follows: • Primary Safety Endpoint: Freedom from serious adverse events (SAEs) related to the procedure through 7 days following the randomization procedure. • Primary Effectiveness Endpoint: Acute procedure success defined as the ability to successfully ablate AF sources identified by the EGF algorithm. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following safety and efficacy secondary endpoints will be evaluated to support the results of the primary endpoints: • Secondary Safety Endpoint: Freedom from serious adverse events (SAEs) related to the procedure through 12 months following the randomization procedure. • Secondary Efficacy Endpoints: o Consistency of sources identified by the Ablacon® EGF algorithm between the randomization procedure and any subsequent EGF-guided ablation procedures o Freedom from documented episodes of AF recurrence following the blanking period (90 days post ablation) through 12 months o Total number of EGF source ablations o Total time of EGF source ablations o Total fluoroscopy time and dose o Overall procedure time | — |
Countries
Netherlands
Outcome results
None listed