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

NCT03852420 | Withdrawn DMC FDA Device

• 1 other identifier: PA002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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.

  0-12 months post procedure

• 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)\*

  0-12 months post procedure

Secondary Outcomes (2)

• Secondary Safety Endpoint

  12 months

• Acute procedural success

  1 day

Study Arms (1)

Treatment with the LUMINIZE RF Balloon Catheter

EXPERIMENTAL

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

Device: LUMINIZE RF Balloon Catheter

Interventions

LUMINIZE RF Balloon Catheter DEVICE

Ablation Therapy with the LUMINIZE RF Balloon Catheter

Treatment with the LUMINIZE RF Balloon Catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \. 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)
• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oussama Wazni

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: January 31, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share