Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation

NCT03639597 | Completed DMC

• 1 other identifier: 980-06114-00
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a single center, open-label, single arm, prospective pre-market study designed to assess the safety and efficacy of the VytronUS Ablation System (VAS) for the treatment of atrial fibrillation in patients with drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

ablation; ultrasound; automation; catheter

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy - Acute success and chronic freedom from AF, AFL and AT lasting longer than 30 seconds, freedom from new class I or II AAD

  Acute (or technical) procedural success defined as PVI documented by confirmed entrance block. Chronic success defined by freedom from symptomatic AF, AT and AFL lasting longer than 30 seconds, freedom from new class I or II AAD and no repeat ablation through 12 months of follow-up.

  12 months

• Primary Safety - incidence of acute AEs occurring within 7 days of procedure and chronic adverse events

  Acute major AEs occurring within 7 days of procedure and chronic AEs defined as symptomatic PV stenosis \>70% or symptomatic atrio-esophageal fistula diagnosed within 12 months.

  12 months

Study Arms (1)

Study device

EXPERIMENTAL

VytronUS Ablation System

Device: VytronUS Ablation System

Interventions

VytronUS Ablation System DEVICE

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:
• a.Episodes of AF i.≥2 recurrent AF episodes of more than 30 seconds' duration that self-terminate and lasting no more than 7 continuous days or ii.Episodes of AF ≤ 48 hours duration terminated with electrical or pharmacologic cardioversion count as a paroxysmal atrial fibrillation episode b.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:

• Non-paroxysmal AF (e.g. persistent, long-standing persistent, or permanent AF)
• AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
• Prior LA ablation or surgery
• Women known to be pregnant or breastfeeding or of childbearing potential unless on satisfactory contraceptive routine
• NYHA Class III or IV congestive heart disease
• LVEF \<40% measured by acceptable cardiac testing (eg. TTE, TEE)
• Anteroposterior LA diameter \>5.5cm or \<3.0cm by TTE
• 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
• Presence of a cardiac valve prosthesis
• Bleeding diathesis or contraindication to anticoagulation therapy
• Blood clotting abnormalities (genetic)
• MI, PCI, invasive cardiac procedure or surgery within 90 days prior to the index ablation procedure
• Previous CVA, TIA, or PE within 3 months prior to the index procedure

Sponsors & Collaborators

• VytronUS, Inc.: lead

Study Sites (1)

Na Homolce

Prague, Czechia

Location

Related Publications (1)

• Turagam MK, Petru J, Neuzil P, Kakita K, Kralovec S, Harari D, Phillips P, Piazza D, Whang W, Dukkipati SR, Reddy VY. Automated Noncontact Ultrasound Imaging and Ablation System for the Treatment of Atrial Fibrillation: Outcomes of the First-in-Human VALUE Trial. Circ Arrhythm Electrophysiol. 2020 Mar;13(3):e007917. doi: 10.1161/CIRCEP.119.007917. Epub 2020 Feb 12.

  PMID: 32078362 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

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: July 17, 2018
• First Posted: August 21, 2018
• Study Start: January 18, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

CZ (1)