Clinical trial NCT03852420: Boston Scientific's Single Shot LUMINIZE RF Balloon Catheter in the Treatment of Symptomatic, Drug Refractory Paroxysmal Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

1. 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:

   i) 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.
2. Subjects who are eligible for an ablation procedure for PAF according to 2017 HRS expert consensus statement on catheter ablation of atrial fibrillation.
3. Subjects refractory or intolerant to at least one class I or III antiarrhythmic medication.
4. Subjects who are willing and capable of providing informed consent.
5. Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center.
6. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

* 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:

  1. Left ventricular ejection fraction \< 40% based on the most recent transthoracic echocardiogram (TTE) performed (≤ 180 days prior to enrollment)+
  2. 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+
  3. An implanted pacemaker, ICD, CRT device or an arrhythmia loop recorder
  4. Subjects with heart failure and New York Heart Association (NYHA) Class III or IV (≤ 180 days prior to enrollment)
  5. Previous cardiac surgery i.e. ventriculotomy or atriotomy, excluding atriotomy for coronary artery bypass graft (CABG)
  6. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve, including mitral valve clips
  7. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder
  8. Presence of left atrial appendage occlusion device
  9. Presence of any pulmonary vein stents
  10. Documented or suspected stenosis of any pulmonary veins
  11. CABG, percutaneous transluminal coronary angioplasty (PTCA)/ percutaneous coronary intervention (PCI)/ coronary stent procedures within 90 days prior to enrollment
  12. Unstable angina or ongoing myocardial ischemia
  13. Previous myocardial infarction within 90 days prior to enrollment
  14. Moderate or severe mitral stenosis assessed on the most recent TTE ≤180 days prior to enrollment as pulmonary artery systolic pressure \>30 mmHg(1)
  15. Vena cava embolic protection filter devices and/ or known femoral thrombus who require catheter insertion from the femoral approach
  16. 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.

Primary outcomes:
measure: Safety event free rate at 12 months post procedure.
timeFrame: 0-12 months post procedure
measure: Failure free rate at 12 months post procedure.
timeFrame: 0-12 months post procedure
Secondary outcomes:
measure: Secondary Safety Endpoint
timeFrame: 12 months
measure: Acute procedural success
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Oussama Wazni
role: PRINCIPAL_INVESTIGATOR
References: