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

NCT ID: NCT03852420

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with the LUMINIZE RF Balloon Catheter

Subjects undergoing cardiac ablation procedure LUMINIZE™ RF Balloon Catheter System.

Group Type: EXPERIMENTAL

LUMINIZE RF Balloon Catheter

Intervention Type: DEVICE

Ablation Therapy with the LUMINIZE RF Balloon Catheter

Interventions

LUMINIZE RF Balloon Catheter

Ablation Therapy with the LUMINIZE RF Balloon Catheter

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oussama Wazni

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Other Identifiers

PA002

Identifier Type: -

Identifier Source: org_study_id