NL-OMON40478已完成4 期
VICTORY AF evaluation of multielectrode phased RF technology in persistent Atrial Fibrilation - VICTORY AF
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Medtronic
- 入组人数
- 20
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
- •* History of symptomatic persistent or long-standing persistent atrial fibrillation defined as:
- •o Persistent AF: sustained AF lasting > 7 days and less than one year, or lasting <
- •7 days but necessitating pharmacologic or electrical cardioversion; OR
- •o Long-standing persistent AF: sustained AF lasting at least 1 year, but no more
- •than 4 years in duration.
- •o Continuous AF as demonstrated on a 48-hour Holter at baseline
- •o AF symptoms defined as the manifestation of:
- •* Palpitations
- •* Exertional dyspnea
- •* Increased intolerance to routine activities (exercise intolerance)
- •* Age between 18 and 70
- •* Failure of at least one class I or III rhythm control AAD
排除标准
- •Structural heart disease of clinical significance including:
- •o Previous cardiac surgery other than CABG or mitral valve repair
- •o NYHA Class III or IV CHF and/or documented ejection fraction <40%
- •measured by acceptable cardiac testing
- •o Left atrial diameter of >55mm
- •o Moderate to severe mitral or aortic valvular heart disease
- •o Stable/unstable angina or ongoing myocardial ischemia
- •o Myocardial infarction (MI) within three months of enrollment
- •o Congenital heart disease other than ASD or PFO without a right to left shunt
- •where the underlying abnormality increases the risk of an ablative procedure
- •o Prior ASD or PFO closure with a device using a percutaneous approach
- •o Hypertrophic cardiomyopathy (LV septal wall thickness >1.5 cm)
- •o Pulmonary hypertension (mean or systolic PA pressure >50mm Hg on Doppler
- •* Any prior ablation for atrial fibrillation in the left atrium
- •* Enrollment in any other ongoing arrhythmia study protocol
- •* Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the
- •management may interfere with this study
- •* Active infection or sepsis
- •* Any history of cerebral vascular disease including stroke or TIAs
- •* Pregnancy or lactation
- •* Left atrial thrombus at the time of ablation
- •* Untreatable allergy to contrast media
- •* Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or
- •any other reversible or non-cardiovascular causes
- •* History of blood clotting (bleeding or thrombotic) abnormalities
- •* Known sensitivities to heparin or vitamin K antagonists (ie. Warfarin/Coumadin)
- •* Prescribed to direct thrombin or factor inhibitors
- •* Severe COPD (defined as an FEV1 <1)
- •* Severe co-morbidity or poor general physical/mental health that, in the opinion of the
- •Investigator, will not allow the subject to be a good study candidate (i.e. other disease
- •processes, mental capacity, substance abuse, shortened life expectance, etc.)
- •* MRI contraindicated
- •* Any invasive cardiovascular procedure performed or planned within the 3 month period
- •prior to the ablation procedure
研究者
相似试验
终止
不适用
Evaluation of the Phased Radio Frequency Ablation SystemPersistent Atrial FibrillationNCT01693120Medtronic Cardiac Ablation Solutions199
已完成
4 期
Efficacy of a combined multi-polar radiofrequency with pulsed electromagnetic field technology for the treatment of vaginal laxity: a double-blinded, randomized, controlled trialvaginal laxityMulti-polarRadiofrequencyPulsed Electromagnetic Field TechnologyVaginal LaxityTCTR20200803002Division of Dermatology, Ramathibodi Hospital32
已完成
2 期
Anti aging efficacy of radiofrequency system of Beaty skin device.IRCT20190210042676N11Fanavari Faragard Company20
尚未招募
Unknown
PROSPECTIVE EVALUATION OF EFFICACY OF RADIOFREQUENCY ABLATION OF SACROILIAC JOINT FOR CHRONIC LOW BACK PAICTRI/2023/04/051976not applicable
尚未招募
1 期
Effectiveness of Radiofrequency Assisted Inferior Turbinoplasty in Symptomatic Patients with Inferior Turbinate HypertrophyCTRI/2024/02/062221SUBHATHRA R