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

Primary Purpose

Paroxysmal Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

VytronUS Ablation System

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring ablation, ultrasound, automation, catheter

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
Structural heart defect that, in the investigator's opinion, prevents catheter access or increases risk of ablation procedure
Pacemaker, ICD, or CRT implantation within 6 months prior to the index ablation procedure
Active systemic infection
Subject contraindicated for both MRI and CT
Life expectancy less than 360 days in physician's opinion
Participation in a drug or device study
Exclusion as per local laws -

Sites / Locations

Na Homolce

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study device

Arm Description

VytronUS Ablation System

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03639597

First Posted

July 17, 2018

Last Updated

April 23, 2019

Sponsor

VytronUS, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03639597

Brief Title

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

Acronym

VALUE

Official Title

Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation - The VALUE Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

January 18, 2016 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VytronUS, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Subjects with documented symptomatic, recurrent, PAF refractory to at least one beta blocker, calcium channel blocker or Class I or Class III anti-arrhythmic drug, who meet all inclusion/exclusion criteria and are deemed appropriate candidates for catheter ablation will undergo PV ablation with the VAS. Pre-procedural CT scan or MRI will be obtained to assess LA and PV anatomy and size. PV ablation will be performed utilizing the VAS (see procedure description below). Acute post-ablation confirmation of PV electrical isolation will be evaluated via standard mapping techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Paroxysmal Atrial Fibrillation

Keywords

ablation, ultrasound, automation, catheter

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study device

Arm Type

Experimental

Arm Description

VytronUS Ablation System

Intervention Type

Device

Intervention Name(s)

VytronUS Ablation System

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 months

Title

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

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 Structural heart defect that, in the investigator's opinion, prevents catheter access or increases risk of ablation procedure Pacemaker, ICD, or CRT implantation within 6 months prior to the index ablation procedure Active systemic infection Subject contraindicated for both MRI and CT Life expectancy less than 360 days in physician's opinion Participation in a drug or device study Exclusion as per local laws -

Facility Information:

Facility Name

Na Homolce

City

Prague

Country

Czechia

12. IPD Sharing Statement

Citations:

PubMed Identifier

32078362

Citation

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.

Results Reference

derived

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

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