Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Cardiac Ablation Solutions
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
Failure or intolerance of at least one Class I or III antiarrhythmic drug
Age 18 or older (or older than 18 if required by local law)
You may not be if
Left atrial diameter \> 5.0 cm (anteroposterior)
Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
Presence of any pulmonary vein stents
Presence of any pre-existing pulmonary vein stenosis
Pre-existing hemidiaphragmatic paralysis
Presence of any cardiac valve prosthesis
+3 and +4 mitral valve regurgitation or stenosis
Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the consent date
Unstable angina
New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. Transthoracic echocardiogram (TTE))
Primary pulmonary hypertension
Rheumatic heart disease
Thrombocytosis, thrombocytopenia
Any condition contraindicating chronic anticoagulation
Active systemic infection
Hypertrophic cardiomyopathy
Cryoglobulinemia
Uncontrolled hyperthyroidism
Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date
Any woman known to be pregnant or breastfeeding, or any woman of child bearing potential who is not on a reliable form of birth regulation method or abstinence
Life expectancy less than one year
Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
Known allergies or hypersensitivities to adhesives
Known drug or alcohol dependency
Unwilling or unable to comply fully with study procedures and follow-up
