Efficacy Comparison of High and Very High Power Short Duration Pulmonary Vein Isolation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Pulmonary vein reconnection
研究概览
简要总结
Objective: To evaluate the long-term durability of PVI performed with 90W and 50W (QDot catheter).
Primary hypothesis: Pulmonary vein isolation performed with 90W (QMODE+) and inter-tag distance <5 mm is non-inferior to pulmonary vein isolation performed with 50W guided by ablation index (QMODE) and inter-tag distance <5 mm.
Study Design: 40 patients will be randomized in a 1:1 ratio to 50W and 90W PVI.
Study procedures: Initial PVI will be performed via femoral access and double transseptal puncture guided by fluoroscopy and pressure monitoring. If necessary intracardiac echocardiography (ICE) will be used for the transseptal puncture. A fast anatomical left atrial map will be created with a multipolar mapping catheter; then, point-by-point PVI will be performed with QDot catheter with 50W or 90W according to randomization. Three months after the initial procedure, patients will undergo a repeated high density left atrial mapping with PentaRay or OctaRay catheter to evaluate the durability of the PVI. Exact gap numbers and locations will be registered. If necessary, reablation of the pulmonary veins (rePVI) will be performed.
Inclusion criteria: Symptomatic paroxysmal/persistent AF, >18 years, willingness to sign informed consent form.
Exclusion criteria: Long-standing persistent AF, active malignancy, contraindication for anticoagulant therapy, life expectancy <1 year, valvular AF, hyperthyroidism.
Endpoints: At repeat procedure, a high density left atrial map will be created with PentaRay or if available OctaRay catheter to evaluate the durability of the PVI. Primary endpoint will be pulmonary vein reconnection.
详细描述
- Background
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in adults. Its prevalence increases with age, affecting 3/100 people, and its incidence is also correlated with age, affecting 30/100,000 people per year. Its clinical significance stems from common complications (stroke, heart failure) and concomitant higher mortality.
The most effective treatment method of atrial fibrillation is catheter ablation, which seeks to maintain sinus rhythm. Isolation of the triggering pulmonary veins (PVI) from the left atrium is the cornerstone of AF ablation. PVI has undergone significant technical development over the past decade; however, the chances of arrhythmia recurrence and the occurrence of procedural complications are not negligible.
Experiments have shown that lesions with a larger surface diameter but less depth develop during HPSD ablation; the higher the energy is, the shallower and wider the lesions are. These lesion properties make it easier to create a solid line from the ablation points, while the shallower lesion causes less damage to the surrounding tissues. The latest application of HPSD technology is the so-called "very high power short duration" (vHPSD) ablation when we apply 90W power. No data are available on long-term efficacy or safety comparing ablation with HPSD vs. vHPSD. 2. Objective: To evaluate the durability of radiofrequency PVI performed with 90W (QMODE plus) and 50W (QMODE) with the QDot catheter. 3. Primary hypothesis: Pulmonary vein isolation performed with 90W (QMODE+) and inter-tag distance <5 mm is non-inferior to pulmonary vein isolation performed with 50W guided by ablation index (QMODE) and inter-tag distance <5 mm. 4. Study Design: Single-center, prospective, randomized study. Patients will be randomly assigned in a 1:1 ratio to HPSD (50W) and vHPSD (90W) PVI. 5. Research period Planned research period from the second quarter of 2022 for a maximum of 1 year. 6. Study subjects
• Planned number of included subjects: 40. 7. Study procedures:
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic paroxysmal/persistent AF
- •Age >18 years
- •Willingness to sign informed consent form.
排除标准
- •Contraindication to ablation
- •Contraindication of long-term anticoagulation
- •Long-standing persistent AF
- •History of PVI
- •History of cardiac surgery
- •Pregnancy
- •Active malignancy
- •Life expectancy <1 year
- •Valvular AF
- •Reversible cause of AF (e.g. hyperthyroidism).
结局指标
主要结局
Pulmonary vein reconnection
时间窗: 3 month
Presence or absence of pulmonary vein reconnection at 3 month remapping procedure
次要结局
- First pass isolation(Immediately after the procedure)
- Acute reconnection(Immediately after the procedure)
- Procedure time(Immediately after the procedure)
- Fluoroscopy time(Immediately after the procedure)
- Fluoroscopy dose(Immediately after the procedure)
- Major complication(3 month)
- Major complication of the second (remapping) procedure(1 week)
- 12-month atrial fibrillation freedom(12 months)
研究者
Nandor Szegedi
Assistant Professor
Semmelweis University