Clinical Evaluation of the StablePoint Catheter and Force-Sensing System for Paroxysmal Atrial Fibrillatio
- Conditions
- Atrial Fibrillation - Abnormal heart rhythm10007521
- Registration Number
- NL-OMON50243
- Lead Sponsor
- Boston Scientific
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
* History of recurrent symptomatic Paroxysmal Atrial Fibrillation (PAF),
defined as atrial fibrillation (AF) that terminates spontaneously or with
intervention (either procedure or drug therapy) within seven days of onset.
Minimum documentation includes the following:
o a physician*s note indicating recurrent self-terminating atrial fibrillation
(AF) which includes at least two symptomatic AF episodes in the patient*s
history within the last 6 months prior to enrollment, and
o any 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 class 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.
* Subjects with New York Heart Association (NYHA) Class III or IV heart failure
< 180 days prior to enrollment
* Left atrial diameter > 5.0 cm or left atrial volume >50 ml/m² indexed based
on the most recent echocardiography
* Left ventricular ejection fraction < 35% based on the most recent
echocardiogram
* Continuous AF lasting longer than seven (7) days
* Subjects who have undergone any previous left atrial cardiac ablation (RF,
Cryo, surgical)
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or
reversible or non-cardiac cause
* Subjects who have undergone any cardiac ablation or any surgery within 30
days prior to enrollment
* Currently implanted with a pacemaker, ICD, CRT device, or an implanted
arrhythmia loop recorder
* Active systemic infection
* Unstable angina or ongoing myocardial ischemia
* Myocardial Infarction (MI) within 90 days prior to enrollment
* Evidence of myxoma, left atrial thrombus or intracardiac mural thrombus
* Previous cardiac surgery (i.e. ventriculotomy, atriotomy, CABG, PTCA, PCI,
coronary stenting procedures) * 90 days prior to enrollment.
* Severe valvular disease, including mechanical prosthetic mitral or tricuspid
heart valves (patients with successful mitral valve repair allowed * annular
ring constitutes repair);
* Any prior history of documented cerebral infarct, TIA or systemic embolism
[excluding a post-operative deep vein thrombosis (DVT)] <180 days prior to
enrollment
* Moderate or severe mitral stenosis (severity assessed on the most recent TTE
*180 days prior to enrollment. Defined as pulmonary artery systolic pressure
>30 mmHg)
* Presence of left atrial appendage closure device
* Interatrial baffle, closure device, patch, or patent foramen ovale (PFO)
occluder
* Subjects who, in the judgment of the investigator, have a life expectancy of
less than two (2) years
* Women of childbearing potential who are, or plan to become, pregnant during
the time of the study (method of assessment upon investigator*s discretion)
* Amiodarone use within 60 days prior to enrollment
* Any carotid stenting or endarterectomy
* Stage 3B renal disease or higher (estimated glomerular filtration rate, eGFR
<45 mL/min)
* Known coagulopathy disorder (e.g. von Willebrand*s disease, hemophilia)
* Any known contraindication to an AF ablation
* Any known contraindication for anticoagulation (e.g. patients unable to
receive heparin or an acceptable alternative to achieve adequate
anticoagulation)
* Vena cava embolic protection filter devices and/or known femoral thrombus
that prevents catheter insertion from the femoral approach
* Known sensitivity to contrast media (if needed during the procedure) that
cannot be controlled with pre-medication
* Rheumatic Heart Disease
* Presence of intramural thrombus, tumor or other abnormality that precludes
vascular access, or manipulation of the catheter
* Subjects unable or unwilling to complete follow-up visits and examinations
for the duration of the clinical study
* 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method