Cardiac arrhythmia recurrent paroxysmal atrial fibrillation
Conditions
Interventions
Patients will receive a catheter-based cardiac ultrasound anatomical mapping
and ablation
procedure using the VAS.
Ablation
Atrial Fibrillation
ultrasound
Sponsors
VytronUS, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years 2. History of symptomatic recurrent paroxysmal atrial fibrillation (PAF) in the prior year, defined by: a. Two or more symptomatic AF episodes lasting greater than 30 seconds duration that self-terminate and lasting no more than 7 continuous days. An episode of AF * 48 hours duration terminated with electrical or pharmacologic cardioversion counts as a paroxysmal atrial fibrillation episode. b. At least one episode of paroxysmal atrial fibrillation (PAF) documented on 12-lead ECG, event monitor, or telemetry monitor in the prior year 3. Paroxysmal atrial fibrillation refractory to at least one Beta Blocker, Calcium Channel Blocker, or Class I or Class III anti-arrhythmic drug (AAD). 4. Subject is indicated for a pulmonary vein ablation according to society guidelines or investigational site practice. 5. Subject is able and willing to give informed consent. 6. Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study
Exclusion criteria
Exclusion criteria: 1. Prior LA ablation or surgery 2. Persistent, longstanding persistent, or permanent AF 3. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause 4. NYHA Class III or IV congestive heart failure 5. Rheumatic heart disease 6. Atrial myxoma 7. LVEF 5.5cm or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: The primary safety endpoint will report the incidence of early onset primary serious adverse events (PSAEs) occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow up period. Effectiveness: The primary effectiveness endpoint of the study will report the rate of treatment success as defined by both: * Acute procedural success - electrical isolation of all 4 pulmonary veins (PVs), or in the event of a common PV, the clinical equivalent of all PVs by the end of index procedure using the VAS. * Chronic success - acute procedural success and freedom from re-treatment with ablation, recurrence of symptomatic atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period. Use of a previously prescribed Class I or III antiarrhythmic drug (AAD) at the same or lower dose, or re-ablation during the blanking period with VAS does not constitute a treatment failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: The secondary safety endpoint will report the incidence of all serious adverse events (SAEs) during the 12 month follow up period. Effectiveness: The secondary effectiveness endpoint will report: * Change in Quality of Life from baseline assessed by 1) European Heart Rhythm Association (EHRA) score of AF-related symptoms, and 2) SF-36 Health Survey * Patients free from atrial arrhythmia on Holter at 12 months | — |
Countries
Belgium, Colombia, Czechia, Germany, Italy, Netherlands, United Kingdom, United States of America
Outcome results
None listed