DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

The DIAMOND-AF II Study is a prospective, non-randomized (single-group assignment) trial being performed at multiple centers in the United States, Canada and Europe to evaluate the safety and effectiveness of the DiamondTemp Ablation System for the treatment of patients with persistent atrial fibrillation.

Inclusion criteria

• Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
• Subjects with a history of documented symptomatic, persistent Atrial Fibrillation with 1) a physician's note documenting a continuous AF episode lasting longer than 7 days but less than 12 months AND 2) two electrocardiograms from any form of rhythm monitoring showing continuous AF taken at least 7 days apart OR a 24-hour Holter within 180 days of the ablation procedure showing continuous AF.
• Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug.
• Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
• Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
• Subject is willing and able to provide written consent.

Exclusion criteria

At time of enrollment and/or prior to procedure:

• Continuous AF >12 months (long-standing persistent AF)
• Paroxysmal AF with longest episode <7 days
• AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
• Rheumatic heart disease
• Severe mitral regurgitation
• Hypertrophic cardiomyopathy
• LA diameter >5.5 cm
• Left ventricular ejection fraction (LVEF) <40%
• Currently NYHA Class III or IV or exhibits uncontrolled heart failure
• Body Mass Index (BMI) >42 kg/m2.
• LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment
• Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation
• Coagulopathy, bleeding diathesis or suspected procoagulant state
• Sepsis, active systemic infection or fever (>100.5 oF / 38 oC) within a week prior to the ablation procedure
• Significant restrictive or obstructive pulmonary disease or chronic respiratory condition
• Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.
• Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
• Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
• Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
• Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.
• Life expectancy <12 months based on medical history or the medical judgement of the investigator.

Within 1 month of enrollment or just prior to procedure:

• Documented LA thrombus upon imaging
• Creatinine >2.5mg/dl or creatinine clearance <30mL/min

Within 3 months of enrollment:

• Significant gastrointestinal (GI) bleed
• Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention

Within 6 months of enrollment:

• Coronary artery bypass graft (CABG) procedure
• Implant procedure performed for ICD, CRT leads or pacemaker
• Documented stroke, CVA, TIA or suspected neurological event