Comparison of Safety and Efficacy of Percutaneous Balloon Aortic Valvuloplasty Performed With or Without Rapid Ventricular Pacing - The Pacing vs No Pacing Study (PNP Study)
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Efficacy endpoint: trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis intention to treat).
研究概览
简要总结
Pilot interventional study, without drug, randomized 1: 1, open-label comparison of efficacy and safety between the technique of percutaneous balloon aortic valvuloplasty without rapid ventricular pacing vs valvuloplasty during rapid ventricular pacing (using a temporary pacemaker device with CE mark). It is expected to enroll 100 patients. Randomization is done through a dedicated computer program.
详细描述
The aim is to compare, in terms of procedural success and safety, the procedure of percutaneous balloon aortic valvuloplasty (BAV) without rapid ventricular pacing with the same procedure carried out with the aid of rapid ventricular pacing.
It is a pilot study with the objective to enroll 100 consecutive patients matching inclusion and exclusion criteria who are randomized 1:1 in two arms: in the first patients undergo procedure of BAV without rapid pacing, in the second BAV with rapid ventricular pacing able to help in balloon stabilization during inflations.
Efficacy will be studied analysing changes in transvalvular gradient from baseline to post-BAV. Safety outcomes will be collected both at discharge and at 30-day. Other procedural data will be object of direct comparison.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of severe symptomatic aortic valve stenosis.
- •no immediate indication to aortic valve replacement (AVR).
- •indication to balloon aortic valvuloplasty (BAV).
- •written expression of informed consent.
排除标准
- •clinical presentation in cardiogenic shock at the time of BAV.
- •clinical presentation in acute pulmonary edema not previously stabilized by medical therapy.
结局指标
主要结局
Efficacy endpoint: trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis intention to treat).
时间窗: Post-procedural, on average 30 minutes after the procedure.
Echocardiography performed 30 minutes after the procedure.
Composite safety endpoint: death, myocardial infarction, stroke, acute aortic valve insufficiency, major bleeding (BARC classification ≥3)
时间窗: 30-day
次要结局
- Ictus incidence(30-day)
- Haemodynamic trans-aortic gradient reduction ≥ 50%(Just after last balloon inflation, on average 3 minutes after BAV)
- Evaluation of variations of the aortic valve area, and the maximum and averageaortic gradient by echocardiography from pre to post procedure(Post-procedural, on average 30 minutes after the procedure.)
- Trans-aortic gradient reduction ≥ 50% measured with echocardiography from baseline to post BAV (analysis per treatment).(Post-procedural, on average 30 minutes after the procedure.)
- Haemodynamic trans-aortic gradient reduction from 30 to 49%(Just after last balloon inflation, on average 3 minutes after BAV)
- Overall mortality(30-day)
- Acute myocardial infarction(30-day)
- Major bleeding (BARC ≥3)(30-day)
- New cardiovascular hospital admission(30-day)
- Trans-aortic gradient reduction from 30 to 49%(Post-procedural, on average 30 minutes after the procedure.)
- Cardiovascular mortality(30-day)
- Acute severe aortic insufficiency(Just after last balloon inflation, on average few seconds after BAV)
研究者
Dr. Antonio Marzocchi
MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna