Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— VITAL  

Official title:

Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03513029
• Other study ID #: 980-08694-00
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: VytronUS, Inc.
• Contact: Director Clinical Affairs
• Phone: +1 408 730 1333
• Email: davidh[@]vytronus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• VytronUS Ablation System
Catheter Ablation for Paroxysmal Atrial Fibrillation

Locations

Country	Name	City	State
Czechia	Na Homolce	Prague

Sponsors (1)

Lead Sponsor	Collaborator
VytronUS, Inc.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety: Incidence of early-onset serious adverse events	Incidence of early-onset serious adverse events	7 days or discharge, whichever is sooner
Primary	Primary Effectiveness: Acute success and chronic freedom from AF, AFL or AT	Acute success and chronic freedom from AF, AFL or AT	12 months
Secondary	Secondary Safety: All serious adverse events	All serious adverse events	12 months