NCT01116557终止4 期
CARTO® 3 System-guided RF Ablation Using the THERMOCOOL® Catheter Versus Fluoroscopy-guided RF Ablation Using the Pulmonary Vein Ablation Catheter® (PVAC®) in Subjects With Paroxysmal Atrial Fibrillation: A Prospective, Multi-center, Randomized (2:1), Controlled, Two-arm, Unblinded Clinical Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 79
- 主要终点
- Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI)
研究概览
简要总结
The purpose of this study is to compare the efficacy, safety and efficiency of CARTO® 3 system guided THERMOCOOL® catheter ablation and fluoroscopy guided Pulmonary Vein Ablation Catheter® (PVAC®) guided ablation for the treatment of paroxysmal atrial fibrillation.
详细描述
This study is a prospective, multi-center, randomized (2:1), controlled, two-arm, unblinded, clinical study, which will evaluate the efficacy, safety, and efficiency of CARTO® 3 System-guided RF ablation (using the THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter) compared to fluoroscopy-guided RF ablation (using the PVAC®). Patients with symptomatic PAF who meet the inclusion criteria will be considered for study participation and may be enrolled if no exclusion criteria apply.
Eligible subjects who signed the study informed consent form will be randomized into one of two treatment groups:
- THERMOCOOL® Group: RF ablation to achieve PVI using the CARTO® 3 System, THERMOCOOL® Catheter and LASSO® Circular Mapping Catheter
- PVAC® Group: RF ablation to achieve PVI using fluoroscopy and the PVAC®
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF (supported by the consensus statement2). At least one AF episode should be documented either on ECG, TTM, HM or telemetry strip.
- •Failure of at least one AAD for PAF [class I or III] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to the AAD.
- •Signed Patient Informed Consent Form.
- •Age 18 years or older.
- •Able and willing to comply with all pre- and follow-up testing and requirements.
排除标准
- •Longstanding persistent atrial fibrillation
- •Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure
- •Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion
- •Previous ablation for AF
- •LA size > 55 mm
- •LVEF < 40% (ejection fraction)
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •CABG procedure within the last six (6) months
- •Awaiting cardiac transplantation or other cardiac surgery
- •Documented left atrial thrombus on imaging (eg, TEE)
- •Diagnosed atrial myxoma
- •Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable) or breastfeeding
- •Acute illness or active systemic infection or sepsis
- •Unstable angina
- •Uncontrolled heart failure
- •Myocardial infarction within the previous two (2) months
- •History of blood clotting or bleeding abnormalities
- •Contraindication to anticoagulation therapy (ie. heparin or warfarin)
- •Life expectancy less than 12 months
- •Enrollment in any other study evaluating another device or drug
- •Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation
结局指标
主要结局
Incidence of PV Stenosis (number of PVs with a reduction in diameter ≥ 50% at 6 months compared to baseline per CT or MRI)
时间窗: at 6 months post-ablation
Freedom from documented AF/AT recurrences without new AADs
时间窗: 1 year follow-up post-ablation
Subjects will be considered a success for the primary efficacy endpoint if the subject is free from documented recurrences of AF or AT lasting more than 30s as measured with Transtelephonic Monitoring and Standard of Care arrhythmia monitoring during a 3-12 month follow-up period post-ablation.
Total procedure time
时间窗: at the time of the initial ablation procedure
次要结局
- Freedom from documented AF/AT recurrences with AAD(s)(through 3-12 month follow-up period post-ablation)
- Incidence of any catheter-related adverse events(during 7 days follow-up post-ablation)
- Total Fluoroscopy Dose-Area Product/Source Intensifier Distance(at the time of the ablation procedure)
- Incidence of any symptomatic Transient Ischemic Attack (TIA) or Cerebrovascular Accident (CVA)(through 1 year follow-up post-ablation)
- Acute procedural success(at the time of the initial ablation procedure)
- Freedom from documented AF/AT recurrences without AAD(s)(through 3-12 month follow-up period post-ablation)
- Freedom from documented AF recurrences with AAD(s)(through 3-12 month follow-up period post-ablation)
- Freedom from documented symptomatic AF/AT recurrences without new AAD(s)(through 3-12 month follow-up period post-ablation)
- Total Fluoroscopy exposure time(at the time of the ablation procedure)
- Incidence of any phrenic nerve paralysis(through 1 year follow-up post-ablation)
- Repeat ablation procedures for AF/AT recurrences(through 3-12 month follow-up period post-ablation)
- Freedom from documented AF/AT recurrences after more than one ablation procedure(through 3-12 month follow-up period post-ablation)
- Freedom from documented AF recurrences without AADs(through 3-12 month follow-up period post-ablation)
- Freedom from documented symptomatic AF/AT recurrences with AAD(s)(through 3-12 month follow-up period post-ablation)
- Incidence of any procedure-related and/or device-related adverse events occurring during the study(through 1 year follow-up)
- Number of mapping and ablation catheters used per subject(through 1 year follow-up post-ablation)
- Quality of Life (SF-36®) and Atrial Fibrillation Symptom Frequency and Severity Checklist assessment(Baseline, 3, 6 and 12 months)
- Total procedure hospital visit and ablation procedure costs(during hospitalization stay for study treatment)
- Total number of initial or prolonged hospitalizations and unscheduled arrhythmia-related health care provider visits (including emergency department visits)(through 1 year follow-up post-ablation)
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