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Paroxysmal Atrial FibrillationVISUALISE AFNCT03852420

Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation

A study testing LUMINIZE RF Balloon Catheter in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To establish the safety and effectiveness of the LUMINIZE RF Balloon Catheter System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PAF). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Paroxysmal Atrial Fibrillation
What is being tested?
LUMINIZE RF Balloon Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
31 Jan 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • History of recurrent symptomatic paroxysmal atrial fibrillation (PAF), defined as atrial fibrillation that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes the following:
  • a physician's note indicating recurrent self-terminating atrial fibrillation (AF) which includes at least two symptomatic AF episodes documented by patient history within last six months from enrollment, and ii) one electrocardiographically documented AF episode within 12 months prior to enrollment.
  • Subjects who are eligible for an ablation procedure for PAF according to 2017 HRS expert consensus statement on catheter ablation of atrial fibrillation.
  • Subjects refractory or intolerant to at least one class I or III antiarrhythmic medication.
  • Subjects who are willing and capable of providing informed consent.
  • Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center.
  • Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Who cannot join

  • 1. Any known contraindication to an AF ablation or anticoagulation 2. Continuous AF lasting longer than seven (7) days from onset 3. History of previous left atrial ablation or surgical treatment for AF/AFL/AT 4. Amiodarone use within 90 days prior to enrollment 5. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 6. Age>80 years 7. Structural heart disease, heart conditions or implanted devices as described below:
  • Left ventricular ejection fraction < 40% based on the most recent transthoracic echocardiogram (TTE) performed (≤ 180 days prior to enrollment)+
  • Left atrial diameter greater than 5.5cm or left atrial volume >50 ml/m² ml indexed based on the most recent TTE performed ≤ 180 days prior to enrollment+
  • An implanted pacemaker, ICD, CRT device or an arrhythmia loop recorder
  • Subjects with heart failure and New York Heart Association (NYHA) Class III or IV (≤ 180 days prior to enrollment)
  • Previous cardiac surgery i.e. ventriculotomy or atriotomy, excluding atriotomy for coronary artery bypass graft (CABG)
Show all 18Show fewer
  • Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve, including mitral valve clips
  • Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
  • Presence of left atrial appendage occlusion device
  • Presence of any pulmonary vein stents
  • Documented or suspected stenosis of any pulmonary veins
  • CABG, percutaneous transluminal coronary angioplasty (PTCA)/ percutaneous coronary intervention (PCI)/ coronary stent procedures within 90 days prior to enrollment
  • Unstable angina or ongoing myocardial ischemia
  • Previous myocardial infarction within 90 days prior to enrollment
  • Moderate or severe mitral stenosis assessed on the most recent TTE ≤180 days prior to enrollment as pulmonary artery systolic pressure >30 mmHg(1)
  • Vena cava embolic protection filter devices and/ or known femoral thrombus who require catheter insertion from the femoral approach
  • Evidence of myxoma, left atrial thrombus or intracardiac mural thrombus++ 8. Stage 3B renal disease or higher (estimated glomerular filtration rate, eGFR <45 mL/min) 9. History of blood clotting or bleeding disease 10. Any prior history of documented cerebral infarct, TIA or systemic embolism [excluding a post-operative deep vein thrombosis (DVT)] ≤180 days prior to enrollment 11. Active systemic infection 12. Pregnant, lactating (current or anticipated during study follow up), or women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion) 13. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility.
  • 14. Subjects who in the judgment of the investigator have a life expectancy of less than two years.

About this study

Official title: Safety and Effectiveness Evaluation of Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation

To establish the safety and effectiveness of the LUMINIZE RF Balloon Catheter System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (PAF).

Read the detailed description

The VISUALISE AF study is a multi-center (global), open label, prospective, single arm study to establish the safety and effectiveness of the LUMINIZE RF Balloon Catheter System. The planned indication for use within the United States for LUMINIZE RF Balloon Catheter System is for the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF).

All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for one year.

Being tested
LUMINIZE RF Balloon Catheter
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LUMINIZE RF Balloon CatheterDevice

    Ablation Therapy with the LUMINIZE RF Balloon Catheter

Study groups in NCT03852420
Study groupRoleWhat they receive
Treatment with the LUMINIZE RF Balloon CatheterExperimentalSubjects undergoing cardiac ablation procedure LUMINIZE™ RF Balloon Catheter System.
Receives: Device: LUMINIZE RF Balloon Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety event free rate at 12 months post procedure.

    Primary safety events will consist of a composite of procedure-related and/or device-related adverse events.

    Measured: 0-12 months post procedure

  2. Failure free rate at 12 months post procedure.

    Failure defined as:

    • Failure to achieve acute procedural success
    • Use of amiodarone post index procedure
    • Surgical treatment for AF/ AFL/ AT post index procedure
    • Use of a non-study ablation catheter for any AF targets in the index procedure or repeat procedure during the blanking period
    • More than one repeat procedure with the LUMINIZE RF Balloon Catheter during the blanking period
    • Documented atrial fibrillation, or new onset of AFL or AT between days 91 post index procedure and 365 days post index procedure captured by one of the following methods:
    • ≥ 30 seconds in duration from the study specific event monitor or Holter Monitor
    • ≥ 10 seconds 12-lead Electrocardiography (ECG)
    • Any of the following interventions for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia between days 91 post index procedure and 365 days:
    • Repeat procedure
    • Cardioversion for AF/AFL/AT
    • Prescribed any antiarrhythmic drug (AAD)*

    Measured: 0-12 months post procedure

Secondary outcomes (2)

  1. Secondary Safety Endpoint

    Serious Adverse Events (SAE) and Adverse Events (AE) related to the procedure and/or study device through 12 months post Index Procedure.

    Measured: 12 months

  2. Acute procedural success

    Rate of acute procedural success defined as the achievement of electrical isolation of all pulmonary veins (PVs) by using the LUMINIZE RF Balloon Catheter system.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2019
  2. Study start31 Jan 2021 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Why it stopped: Sponsor discretion

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The LUMINIZE RF Balloon Catheter is a multi-electrode, irrigated, over-the-wire balloon catheter designed to facilitate cardiac electrophysiological mapping and ablation. The catheter interfaces with the LUMINIZE Console and is designed to localize potentials and create lesions using multi-polar RF energy. The System consists of the following devices and components: * LUMINIZE RF Balloon Catheter * LUMINIZE Steerable Sheath * LUMINIZE Console * LUMINIZE System Accessories
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03852420
Sponsor's protocol ID
PA002
Acronym
VISUALISE AF
Status last verified
Jan 2021
First submitted
22 Feb 2019
Last updated
15 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

Questions about this trial

What is this clinical trial studying?

A study testing LUMINIZE RF Balloon Catheter in people with Paroxysmal Atrial Fibrillation, run by Boston Scientific Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety event free rate at 12 months post procedure. (time frame: 0-12 months post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03852420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.

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