WithdrawnNot Applicable

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

Stopped: Sponsor discretion

0Started 2021-01-31

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Safety event free rate at 12 months post procedure.

Timeframe: 0-12 months post procedure

Failure free rate at 12 months post procedure.

Timeframe: 0-12 months post procedure

Trial details

NCT IDNCT03852420

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More Paroxysmal Atrial Fibrillation trials