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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03639597
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
VytronUS, Inc.

Tracking Information
First Submitted Date  ICMJE July 17, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE January 18, 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2018)
  • 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 [ Time Frame: 12 months ]
    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 [ Time Frame: 12 months ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03639597 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation
Official Title  ICMJE Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation - The VALUE Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Paroxysmal Atrial Fibrillation
Intervention  ICMJE Device: VytronUS Ablation System
Study Arms  ICMJE Experimental: Study device
VytronUS Ablation System
Intervention: Device: VytronUS Ablation System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2018)
53
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age between 18 and 75 years
  2. 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

  3. Paroxysmal atrial fibrillation refractory to at least one Beta Blocker, Calcium Channel Blocker, or Class I or Class III anti-arrhythmic drug (AAD).
  4. Subject is indicated for a pulmonary vein ablation according to society guidelines or investigational site practice.
  5. Subject is able and willing to give informed consent.
  6. Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study.

Exclusion Criteria:

  1. Non-paroxysmal AF (e.g. persistent, long-standing persistent, or permanent AF)
  2. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
  3. Prior LA ablation or surgery
  4. Women known to be pregnant or breastfeeding or of childbearing potential unless on satisfactory contraceptive routine
  5. NYHA Class III or IV congestive heart disease
  6. LVEF <40% measured by acceptable cardiac testing (eg. TTE, TEE)
  7. Anteroposterior LA diameter >5.5cm or <3.0cm by TTE
  8. Presence of intracardiac thrombus (including a known history of thrombus) within 30 days prior to the index ablation procedure
  9. Presence of pulmonary vein stent(s)
  10. Presence of pre-existing pulmonary narrowing or pulmonary vein stenosis
  11. Presence of a cardiac valve prosthesis
  12. Bleeding diathesis or contraindication to anticoagulation therapy
  13. Blood clotting abnormalities (genetic)
  14. MI, PCI, invasive cardiac procedure or surgery within 90 days prior to the index ablation procedure
  15. Previous CVA, TIA, or PE within 3 months prior to the index procedure
  16. Structural heart defect that, in the investigator's opinion, prevents catheter access or increases risk of ablation procedure
  17. Pacemaker, ICD, or CRT implantation within 6 months prior to the index ablation procedure
  18. Active systemic infection
  19. Subject contraindicated for both MRI and CT
  20. Life expectancy less than 360 days in physician's opinion
  21. Participation in a drug or device study
  22. Exclusion as per local laws -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03639597
Other Study ID Numbers  ICMJE 980-06114-00
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VytronUS, Inc.
Study Sponsor  ICMJE VytronUS, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account VytronUS, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP