DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.

The DIAMOND-AF study is a prospective, single blind, 1:1 randomized controlled study being performed at multiple centers in the United States, Canada and Europe. The study will evaluate the safety and effectiveness of the DiamondTemp System used for ablation in patients with paroxysmal atrial fibrillation (AF). Subjects will be randomized for treatment with either the DiamondTemp Ablation Catheter or the TactiCath™ Quartz Contact Force Ablation Catheter manufactured by Abbott. Patients will be followed for 12 months.

Eligibility Criteria:
STUDY INCLUSION CRITERIA- Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF study:

1. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
2. Subjects with a history of symptomatic, paroxysmal atrial fibrillation (PAF) who have had ≥2 episodes of PAF reported within the 6 months prior to index ablation procedure with a physician note indicating recurrent, self-terminating AF.
3. At least one episode of PAF documented by electrocardiographic data within the 12 months prior to index ablation procedure.
4. Refractory to at least one Class I-IV AAD for treatment of PAF.
5. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
6. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
7. Subject is willing and able to provide written consent.

STUDY EXCLUSION CRITERIA - Candidates will be excluded from the DIAMOND-AF study if any of the following conditions apply within the following timeframes:

At time of enrollment and/or prior to procedure:

1. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
2. LA diameter \> 5.5 cm.
3. LVEF \< 35%.
4. Currently NYHA Class III or IV or exhibits uncontrolled heart failure.
5. BMI \> 40 kg/m2.
6. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment.
7. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
8. Coagulopathy, bleeding diathesis or suspected procoagulant state
9. Sepsis, active systemic infection or fever (\>100.5°F / 38°C) within a week prior to the ablation procedure.
10. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
11. 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.
12. 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.
13. Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
14. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
15. 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.
16. 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:
17. Documented LA thrombus upon imaging.
18. Creatinine \>2.5mg/dl or creatinine clearance \<30mL/min.

    Within 2 months of enrollment:
19. Regularly (uninterrupted) prescribed amiodarone.

    Within 3 months of enrollment:
20. Significant GI bleed.
21. MI, unstable angina, cardiac surgery or coronary intervention.

    Within 6 months of enrollment:
22. CABG procedure.
23. ICD, CRT leads or pacemaker implant procedure.
24. Documented stroke, CVA, TIA or suspected neurological event.

    Within 12 months of enrollment:
25. An episode of AF lasting \>7 days in duration.