Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation

Korábbi kezelés

• Subjects enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
• Subjects who have undergone any previous left atrial cardiac ablation (RF, Cryo, surgical)
• Subjects who have undergone any cardiac ablation within 30 days prior to enrollment
• Known cardiac thrombus within 60 days prior to enrollment
• History of CVA, TIA or PE within 90 days prior to enrollment
• Implanted pacemaker, ICD, or CRT leads within 90 days prior to enrollment
• Implanted Left atrial appendage closure device prior to the index procedure

Más betegség

• Prosthetic mitral or tricuspid heart valves (subjects with successful mitral valve repair allowed- annular ring constitutes repair)
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Any cardiac surgery ≤ 90 days from consent date.

Egyéb

• Subjects unable or unwilling to complete follow-up visits and examination for the duration of the study
• Unrecovered/unresolved Adverse Events from any previous invasive procedure
• Life expectancy <= three years per physician opinion
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion)
• Left atrial diameter greater than 5.5cm
• Documented or suspected stenosis of any pulmonary veins.
• Contraindication for anticoagulation
• Clinically significant mitral valve regurgitation or stenosis per investigator discretion.
• Any electrocardiographically documented episode of Persistent AFib, defined as AFib lasting longer than 7 days from onset.

• History of recurrent symptomatic Paroxysmal Atrial Fibrillation, defined as AFib that terminates spontaneously or with intervention within seven days of onset. Minimum documentation includes a physician's note indicating recurrent self-terminating Atrial Fibrillation AND one electrocardiographically documented AF episode within 6 months prior to enrollment.
• Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with the Rhythmia Mapping system according to current international and local guidelines
• Subjects who are eligible for an ablation procedure for Paroxysmal Atrial Fibrillation with a Boston Scientific Open-Irrigated Ablation Catheter according to current international and local guidelines
• 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 20 years or above, or who are of legal age to give informed consent specific to state and national law.