Randomized Trial of Conventional Versus Radiofrequency Needle Transseptal Puncture for Cryoballoon Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- Total time required for left atrial access
研究概览
简要总结
This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.
The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
详细描述
Study Objective - The objective of the prospective, randomized study is to evaluate the effectiveness and safety of the Baylis transseptal system (RF needle, TorFlex sheath, and specialised ProTrack guidewire) compared with a conventional transseptal (conventional sheath, Brockenbrough needle, and standard guidewire) for transseptal LA access during cryoballoon ablation procedures.
Trial design - This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.
Study Population - The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-permanent AF documented on a 12 lead ECG, Trans Telephonic Monitoring (TTM) or Holter monitor within the last 24 months
- •Age of 18 years or older on the date of consent
- •Candidate for ablation based on AF that is symptomatic
- •Informed Consent
排除标准
- •Previous left atrial (LA) ablation or LA surgery
- •AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
- •Active Intracardiac Thrombus
- •Pre-existing pulmonary vein stenosis or PV stent
- •Pre-existing hemidiaphragmatic paralysis
- •Contraindication to anticoagulation or radiocontrast materials
- •Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
- •Cardiac valve prosthesis
- •Clinically significant (moderately-severe, or severe) mitral valve regurgitation or stenosis
- •Myocardial infarction, PCI / PTCA, or coronary artery stenting during the 3-month period preceding the consent date
- •Cardiac surgery during the three-month interval preceding the consent date
- •Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
- •NYHA class III or IV congestive heart failure
- •Left ventricular ejection fraction (LVEF) less than 35%
- •Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm)
- •Significant Chronic Kidney Disease (CKD - eGFR <30 µMol/L)
- •Uncontrolled hyperthyroidism
- •Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
- •Pregnancy
- •Life expectancy less than one (1) year
- •Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study
- •Unwilling or unable to comply fully with study procedures and follow-up
结局指标
主要结局
Total time required for left atrial access
时间窗: Intraprocedural assessment (within 24 hours)
defined as time from the first pull-down of the needle/sheath/dilator apparatus in the superior vena cava to first entrance of the cryoballoon into the left atrium.
次要结局
- Plastic Shavings(Intraprocedural assessment of visible plastic shavings (within 24 hours))
- Transseptal time - left atrial access to sheath positioning(Intraprocedural assessment (measured in seconds))
- Transeptal Access(Intraprocedural assessment (within 24 hours))
- The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture(Acute peri-procedural complications will be defined as occurring within 30 days of ablation)
- Transseptal time - septal engagement to sheath advancement(Intraprocedural assessment (measured in seconds))
研究者
Jason Andrade
MD FRCPC FHRS
University of British Columbia