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

NCT03513029 | Unknown DMC

• 1 other identifier: 980-08694-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

PAF; atrial fibrillation; ablation; low intensity collimated ultrasound

Outcome Measures

Primary Outcomes (2)

• Primary Safety: Incidence of early-onset serious adverse events

  Incidence of early-onset serious adverse events

  7 days or discharge, whichever is sooner

• 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 Outcomes (1)

• Secondary Safety: All serious adverse events

  12 months

Study Arms (1)

Study Device

EXPERIMENTAL

VytronUS Ablation System

Device: VytronUS Ablation System

Interventions

VytronUS Ablation System DEVICE

Catheter Ablation for Paroxysmal Atrial Fibrillation

Study Device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• History of symptomatic recurrent paroxysmal atrial fibrillation (PAF) in the prior year, defined by:
• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VytronUS, Inc.: lead

Study Sites (1)

Na Homolce

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Director Clinical Affairs

CONTACT

+1 408 730 1333; davidh@vytronus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 1, 2018
• Study Start: January 20, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)