NCT05477147已完成不适用
Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 38
- 主要终点
- Freedom from AF
研究概览
简要总结
Multi-center, international, non-randomized clinical trial evaluating the use of Volta's VX1 algorithm as used in combination with repeat catheter ablation after AF recurrence after previous catheter ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 21 years of age or older indicated for redo AF ablation
- •Previous catheter or surgical ablation for paroxysmal AF, persistent AF, or long-standing persistent AF
- •Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure
- •Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
- •Patients must be able and willing to provide written informed consent to participate in the clinical trial
排除标准
- •Previous ablation procedure-related complication (e.g. fistula, perforation, etc.)
- •First AF ablation procedure indication was persistent AF lasting longer than 24 months
- •Long-standing persistent AF recurrence prior to study redo procedure
- •Previous AF ablation using VX1 software
- •Severe obesity (BMI > 50)
- •Very dilated Left Atrium (LA) (e.g. LA diameter > 55 mm and/or LA surface > 40 cm2 determined by 2D echocardiography)
- •Patients with AF secondary to an obvious reversible cause
- •Inadequate anticoagulation as defined in the inclusion criteria
- •LA thrombus on Transesophageal Echocardiography (TEE)* or CT Scan prior to procedure
- •Contraindications to anticoagulation (heparin, warfarin or NOAC)
- •Patients who are or may potentially be pregnant
- •Any cardiac surgery except catheter ablation within the past 2 months (60 days) (includes PCI)
- •Myocardial infarction within the past 2 months (60 days)
- •Previous AV valve surgery
- •Patient diagnosed with hypertrophic cardiomyopathy
- •History of blood clotting or bleeding abnormalities
- •Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
- •Rheumatic Heart Disease
- •Cardiac Sarcoidosis
- •Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
- •Unstable angina within the past month
- •Acute illness or active systemic infection or sepsis
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Diagnosed atrial myxoma
- •Significant severe pulmonary disease (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- •Enrollment in an investigational study evaluating another device, biologic, or drug
- •Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
- •Life expectancy or other disease processes likely to limit survival to less than 12 months
- •Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
结局指标
主要结局
Freedom from AF
时间窗: 1 year
Percent of patient free from recurrent AF episodes of \>30 seconds at 1 year after 1 study redo procedure
次要结局
未报告次要终点
研究者
研究点 (38)
Loading locations...
相似试验
已完成
4 期
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.HypertensionNCT00698646Novartis Pharmaceuticals384
进行中（未招募）
2 期
A study of chemotherapy in Hodgkins lymphoma which has come back after initial treatmentCTRI/2019/05/019049JIPMER9
终止
2 期
A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus InfectionChronic Hepatitis C Virus InfectionNCT01080222Vertex Pharmaceuticals Incorporated152
招募中
2 期
Clinical Study Protocol of Venetoclax Combined With Azacitidine and Harringtonine in the Treatment of sAMLSecondary Acute Myeloid LeukemiaNCT05513131The First Affiliated Hospital with Nanjing Medical University30
已完成
不适用
High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute LeukemiaRecurrent Acute Leukemia of Ambiguous LineageRecurrent Acute Lymphoblastic LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Lymphoblastic LeukemiaRefractory Acute Myeloid LeukemiaRefractory Acute Leukemia of Ambiguous LineageNCT02551718University of Washington34