atrial fibrillation cardiac arrhythmia
Conditions
Interventions
None listed
Sponsors
Acutus Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: IC 1 Male or female eighteen (18) years of age or older IC 2 Currently scheduled for a repeat endocardial ablation of AF IC 3 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study IC 4 Willingness and ability to give informed consent
Exclusion criteria
Exclusion criteria: EC 1 In the opinion of the Investigator, any known contraindication to a left-atrial ablation or concerns for left-atrial thrombus EC 2 No more than two (2) previous left-atrial ablations EC 3 Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause EC 4 Structural heart disease or implanted devices as described below: a. An implanted pacemaker or ICD b. Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG) c. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve d. Interatrial baffle, closure device, patch, or PFO occluder e. Presence of a left atrial appendage occlusion device f. Unstable angina or ongoing myocardial ischemia EC 5 History of blood clotting or bleeding disease EC 6 Pregnant or lactating (current or anticipated during study follow up) EC 7 Current enrollment in any study protocol sponsored by Acutus Medical or any other study that may impact the results of RECOVER AF EC 8 Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measurable objectives are a descriptive analysis of the following: - At the procedure conclusion, confirmation of electrical isolation of all pulmonary veins and elimination/modification of all non-PV targets as identified by the AcQMap* System - Recording of all subjects who are atrial fibrillation free from events lasting > 30 seconds at 6-, and 12-months as measured by a 48-hour continuous ECG o A subset analysis of AAD use o A subset analysis of subjects with freedom from AF/AT/AFL events lasting > 30 seconds as measured by a 48-hour continuous ECG - Documentation of procedure data including total time, fluoroscopy time, ablation times for PVI, and ablation times for non-PV targets - Safety * Recording of all device and procedure related safety events during the procedure and throughout the duration of the study | — |
Countries
Netherlands
Outcome results
None listed