Phase
Condition
Atrial Fibrillation
Chest Pain
Arrhythmia
Treatment
CoreMap EP Mapping System Map-Guided Ablation
CoreMap EP Mapping System Mapping
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has persistent or long-standing persistent AF, at the discretion of theinvestigator
Subject is 18 to 80 years of age
Patient scheduled for standard of care AF ablation
Subject is able to provide written informed consent
Subject is able and willing to complete all study procedures
Exclusion
Exclusion Criteria:
Any of the following within three months of enrollment:
Myocardial infarction (MI)
Any surgical or percutaneous cardiac procedure including coronary interventionand cardiac ablation
Confirmed thrombus on imaging
Any of the following within six months of enrollment: a) Cardiac surgery includingcoronary artery bypass grafting, ventriculotomy, atriotomy b) Thromboembolic event (stroke)
Any of the following cardiac conditions:
New York Heart Association (NYHA) IV
Left ventricular ejection fraction (LVEF) < 30%
Carotid stenting or endarterectomy
Atrial or ventricular septal closure or left atrial appendage closure
Implanted permanent pacemaker, biventricular pacemaker, or any type ofimplantable cardiac defibrillator
Presence of intramural thrombus, tumor (including atrial myxoma), or otherabnormality that precludes vascular access, catheter introduction, ormanipulation
Unstable angina
Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
Moderate to severe mitral valve stenosis or other severe valvular disease
Any blood clotting or bleeding abnormalities
Contraindication to systemic anticoagulation
AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible ornon-cardiac cause
Body mass index (BMI) > 40 kg/m2
Severe pulmonary disease, pulmonary hypertension, or any chronic respiratorycondition
Renal failure requiring dialysis or transplant
Acute illness, active systemic infection, or sepsis
Active drug or alcohol dependency
Any contra-indication that may extend procedure time, at the discretion of theoperator
Any woman known to be pregnant or breastfeeding, or any woman of childbearingpotential who is not on a reliable form of birth regulation method or abstinence
Subject considered part of vulnerable population
Life expectancy less than one year
Employee of the study site or Sponsor
Subjects who are currently enrolled in another study that would directly interferewith this study
Study Design
Study Description
Connect with a study center
Na Homolce Hospital
Praha - Klanovice,
CzechiaActive - Recruiting
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