Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 19
- 主要终点
- Recurrent VTA
研究概览
简要总结
To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery
详细描述
This study is a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA who will be randomized in a 1:1 ratio to intra-operative VTA ablation vs. conventional medical management. Comprehensive data on arrhythmia history, medication history will be collected in all randomized subjects. Antiarrhythmic medical therapy will be handled in a uniform pattern between the two arms. Randomized subjects will then be followed per routine schedules for post LVAD implant. Arrhythmia data, ICD therapy, additional procedures including repeat surgery, ramp echocardiographic tests, right heart catheterization and catheter-based VTA ablation will be collected. In addition, adverse events such as unplanned hospitalizations, emergency department visits, clinic visits, and all other aspects of health care utilization will be gathered. The planned average follow-up period will be 18 months.
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
- Single (Outcomes Assessor)
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
- •Age > 18 years
- •Presence of advanced cardiomyopathy (of all INTERMACS classification) and eligible for LVAD implant per the decision of the Heart Failure clinical team
- •Implanted cardioverter defibrillator (ICD) any time in past with remote monitoring or planned to undergo ICD (or ICM as an alternative, if an ICD cannot be implanted for a clinical reason) implant within the index hospitalization for LVAD implant
- •History of treated or monitored sustained (i.e., >30 seconds in duration ) VT or VF episode within the past 5 years.
排除标准
- •Past successful VTA ablation without recurrent VTA prior to LVAD implant (Patients who continue to experience VTA post ablation and pre LVAD implant qualify to be enrolled)
- •Participation in other clinical trials (observational registries are allowed with approval)
- •Unable or unwilling to provide informed consent
研究组 & 干预措施
Intra-Op Prophylactic VT ablation
Subjects will get ablation procedure as needed if they were determined to be refractory to medical antiarrhythmic control should undergo catheter-based electrophysiology study and ablation on LVAD support
干预措施: Intra-Op Prophylactic VT ablation (Procedure)
Conventional Management
To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued
干预措施: Conventional Management (Other)
结局指标
主要结局
Recurrent VTA
时间窗: Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)
Total VTA events, after accounting for the competing risk of death
次要结局
- Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.(Post LVAD implant until end of follow-up, approximately 18 months)
- Mean duration of LVAD implant (and ablation) surgery(Admission for LVAD implant until hospital discharge (approximately 2-4 weeks))
- Mean duration of ablation(Admission for LVAD implant until hospital discharge (approximately 2-4 weeks))
- Mean rate of peri-procedural complication(Admission for LVAD implant until hospital discharge (approximately 2-4 weeks))
- Mean Length of stay in the intensive care unit after LVAD implant(Admission for LVAD implant until hospital discharge (approximately 2-4 weeks))
研究者
David Huang
Professor
University of Rochester