Clinical trial NCT03513029: Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
Official title: Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: PAF
atrial fibrillation
ablation
low intensity collimated ultrasound
Lead sponsor: VytronUS, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Primary Safety: Incidence of early-onset serious adverse events
timeFrame: 7 days or discharge, whichever is sooner
measure: Primary Effectiveness: Acute success and chronic freedom from AF, AFL or AT
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Safety: All serious adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce
Study officials:
References: