NL-OMON56875招募中不适用
Initial Safety and Performance of the CellFX® nsPFA* Cardiac Surgery System for the Treatment of Atrial Fibrillation - CellFX® nsPFA* for the Treatment of Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject must be between 18 and 85 years of age
- •2. Subject is willing and capable of providing Informed Consent to undergo
- •study procedures which includes surgical AF ablation and completing follow-up
- •visits as specified in the clinical study protocol
- •3. Subject has history of documented atrial fibrillation within one year prior
- •to enrollment. Documentation may include ECG, transtelephonic monitor (TTM),
- •holter monitor or telemetry strip
- •4. Subject is scheduled to undergo non-emergent cardiac surgical procedure(s)
- •to be performed on cardiopulmonary bypass including open-heart surgery for one
- •or more of the following: Mitral valve repair or replacement, Aortic valve
- •repair or replacement, Ascending aortic aneurysms, or Coronary artery bypass
- •5. Left ventricular ejection fraction >= 30% (determined by echocardiography or
- •cardiac catheterization performed within 60 days of enrollment as documented in
- •patient medical history)
- •6. Subject has a life expectancy of at least 5 years
排除标准
- •1. Subject has an implantable electronic medical device. (i.e., pacemaker, ICD,
- •or CRT) or left atrial appendage device
- •2. Subject has a prosthetic heart valve
- •3. Stand- alone AF without indication(s) for concomitant Coronary Artery Bypass
- •Graft (CABG) and/or valve surgery
- •4. Previous surgical Maze procedure
- •5. Prior cardiac surgery (Redo)
- •6. Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia,
- •Atrioventricular (AV) nodal reentry
- •7. Subjects requiring surgery other than CABG and/or cardiac valve surgery
- •and/or atrial septal defect repair
- •8. Prior history of medical procedure involving instrumentation of the left
- •atrium (e.g., previous ablation)
- •9. Class IV New York Heart Association (NYHA) heart failure symptoms
- •10. Prior history of cerebrovascular accident or TIA within 6 months or at any
- •time if there is residual neurological deficit
- •11. Documented ST-segment elevation Myocardial Infarction (MI) within the 6
- •weeks prior to study enrollment
- •12. Need for emergent cardiac surgery (i.e., cardiogenic shock)
- •13. Known carotid artery stenosis greater than 80%
- •14. Current diagnosis of active systemic infection
- •15. Severe peripheral arterial occlusive disease defined as claudication with
- •minimal exertion
- •16. Renal failure requiring dialysis or hepatic failure
- •17. A known drug and/or alcohol addiction
- •18. Mental impairment or other conditions which may not allow the subject to
- •understand the nature, significance and scope of the study
- •19. Pregnancy or desire to get pregnant within 12-months of the study treatment
- •20. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- •21. Subjects who have been treated with thoracic radiation
- •22. Subjects in current chemotherapy
- •23. Subjects on long term treatment with oral or injected steroids (not
- •including intermittent use of inhaled steroids for respiratory diseases)
- •24. Subjects with known hypertrophic obstructive cardiomyopathy
- •25. Subjects with known cold agglutinin
- •26. History of abnormal bleeding and/or clotting disorder
- •27. Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban,
- •Vitamin K Antagonists such as warfarin)
- •28. Solid organ or hematologic transplant, or currently being evaluated for an
- •organ transplant
- •29. Body mass index > 40 kg/m2
- •30. Use of any other investigational drug, therapy, or device within 30 days
- •prior to enrollment or concurrent participation in another research study
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