Paroxysmal Atrial Fibrillation
Conditions
Keywords
PAF, atrial fibrillation, ablation, low intensity collimated ultrasound
Brief summary
VITAL is a prospective, single arm, multicenter, interventional study to evaluate the safety and effectiveness of the VytronUS Ablation System (VAS) for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using low intensity collimated ultrasound (LICU) for imaging and ablation.
Detailed description
Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated consistent with the 2012 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Expert Consensus Statement on Catheter and Surgical Ablation for Atrial Fibrillation. Eligible patients will receive treatment with the VAS including ultrasound imaging of the left atrium and cardiac ablation to electrically isolate the pulmonary veins. Up to 100 patients will be enrolled at up to 10 sites in Europe (EU) and in the United States (US).
Interventions
DEVICEVytronUS Ablation System
Catheter Ablation for Paroxysmal Atrial Fibrillation
Sponsors
VytronUS, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years * History of symptomatic recurrent paroxysmal atrial fibrillation (PAF) in the prior year, defined by: 1. 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. 2. At least one episode of paroxysmal atrial fibrillation (PAF) documented on 12-lead ECG, event monitor, or telemetry monitor in the prior year * Paroxysmal atrial fibrillation refractory to at least one Beta Blocker, Calcium Channel Blocker, or Class I or Class III anti-arrhythmic drug (AAD). * Subject is indicated for a pulmonary vein ablation according to society guidelines or investigational site practice. * Subject is able and willing to give informed consent. * Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study
Exclusion criteria
* Prior LA ablation or surgery * Persistent, longstanding persistent, or permanent AF * AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause * NYHA Class III or IV congestive heart failure * Rheumatic heart disease * Atrial myxoma * LVEF \<40% measured by acceptable cardiac testing (e.g. TTE, TEE) * Anteroposterior LA diameter \>5.5cm or \<3.5cm by TTE, CT or MRI * Presence of intracardiac thrombus (including a known history of thrombus) within 30 days prior to the index ablation procedure * Presence of pulmonary vein stent(s) * Presence of pre-existing pulmonary narrowing or pulmonary vein stenosis greater than 70% * Presence of pre-existing pericardial effusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety: Incidence of early-onset serious adverse events | 7 days or discharge, whichever is sooner | Incidence of early-onset serious adverse events |
| Primary Effectiveness: Acute success and chronic freedom from AF, AFL or AT | 12 months | Acute success and chronic freedom from AF, AFL or AT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety: All serious adverse events | 12 months | All serious adverse events |
Countries
Czechia
Contacts
Primary ContactDirector Clinical Affairs
Outcome results
None listed