Safety and Effectiveness IDE trial for Boston Scientific*s Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillatio
- Conditions
- Atrial Fibrilation - Abnormal heart rhythm1000752110007593
- Registration Number
- NL-OMON51083
- Lead Sponsor
- Boston Scientific
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
• 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.
• No amiodarone use within 90 days prior to enrollment
• Subjects who are indicated for an ablation procedure for paroxysmal atrial
fibrillation (PAF) according to 2017 HRS expert consensus statement on catheter
and surgical ablation of atrial fibrillation
• Subjects refractory or intolerant to at least one class I or III
antiarrhythmic medication or contraindicated to any class I or III medications
• 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
• Any known contraindication to an AF ablation or anticoagulation
• Continuous AF lasting longer than seven (7) days from onset
• History of previous left atrial ablation or surgical treatment for AF/ AFL/ AT
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or
any other reversible or non-cardiac cause
• Structural heart disease or implanted devices as described below:
a. Left ventricular ejection fraction (LVEF) < 40% based on most recent
transthoracic echocardiogram (TTE) performed <=180 days prior to enrollment *
b. Left atrial diameter > 5.5 cm OR left atrial volume > 50 ml/m2 indexed based
on the most recent TTE performed <= 180 days prior to enrollment *
c. An implanted pacemaker, ICD, CRT device or an arrhythmia loop recorder
d. Previous cardiac surgery: i.e. ventriculotomy or atriotomy (excluding
atriotomy for CABG)
e. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic
valve, including mitral valve clips
f. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO)
occluder
g. Presence of a left atrial appendage occlusion device
h. Presence of any pulmonary vein stents
i. Coronary artery bypass graft (CABG), PTCA/ PCI/ coronary stent procedures
within 90 days prior to enrollment
j. Unstable angina or ongoing myocardial ischemia
k. Myocardial infarction within 90 days prior to enrollment
l. Moderate or severe mitral stenosis [severity assessed on the most recent TTE
<=180 days prior to enrollment as pulmonary artery systolic pressure >30 mmHg(1)]
m. Evidence of left atrial thrombus**
• Any previous history of cryoglobulinemia
• Stage 3B or higher renal disease (estimated glomerular filtration rate, eGFR
<45 mL/min)
• History of blood clotting or bleeding disease
• Any prior history of documented cerebral infarct, TIA or systemic embolism
[excluding a post-operative deep vein thrombosis (DVT)] <=180 days prior to
enrollment
• Active systemic infection
• 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)
• 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
• Subjects who in the judgment of the investigator have a life expectancy of
less than two years
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method