Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects indicated for drug refractory, recurrent symptomatic PAF treatment with the Cryoablation System, per physician's medical judgement, and as per standard of care
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 study at an approved clinical investigational center;
You may not be if
Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU as legally approved conditions;
Any prior LA ablation;
Known or pre-existing severe PV Stenosis;
Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
Presence of any pulmonary vein stents;
Subjects with active systemic infection;
Subject is unable or not willing to complete follow-up visits and examination for the duration of the study;- Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);