Back to resultsClinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation (VITAL)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
VytronUS Ablation System
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring PAF, atrial fibrillation, ablation, low intensity collimated ultrasound
Eligibility Criteria
Inclusion Criteria:
- 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
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
Sites / Locations
- Na HomolceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Device
Arm Description
VytronUS Ablation System
Outcomes
Primary Outcome Measures
Primary Safety: Incidence of early-onset serious adverse events
Incidence of early-onset serious adverse events
Primary Effectiveness: Acute success and chronic freedom from AF, AFL or AT
Acute success and chronic freedom from AF, AFL or AT
Secondary Outcome Measures
Secondary Safety: All serious adverse events
All serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03513029
Brief Title
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
Acronym
VITAL
Official Title
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
PAF, atrial fibrillation, ablation, low intensity collimated ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
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
Intervention Description
Catheter Ablation for Paroxysmal Atrial Fibrillation
Primary Outcome Measure Information:
Title
Primary Safety: Incidence of early-onset serious adverse events
Description
Incidence of early-onset serious adverse events
Time Frame
7 days or discharge, whichever is sooner
Title
Primary Effectiveness: Acute success and chronic freedom from AF, AFL or AT
Description
Acute success and chronic freedom from AF, AFL or AT
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Secondary Safety: All serious adverse events
Description
All serious adverse events
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
No
Eligibility Criteria
Inclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director Clinical Affairs
Phone
+1 408 730 1333
Email
davidh@vytronus.com
Facility Information:
Facility Name
Na Homolce
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study coordinator
Email
Katerina.Mzourkova@homolka.cz
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation of the VytronUS Ablation System for Treatment of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillation
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