SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation; a Prospective Registry (SAPPHIRE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Register which TAVI LV-guidewires are used in contemporary practice
研究概览
简要总结
The goal of this observational study is to document which LV-guidewires are used during a TAVI (Transcatheter Aortic Valve Implantation) procedure and how their different functions perform.
A TAVI procedure is a minimally invasive treatment for aortic stenosis, where a new heart valve is inserted through a blood vessel in the groin. During this procedure, a wire (specifically, an LV-guidewire) is used to place the new heart valve. For this purpose, a regular LV-guidewire or a newer LV-guidewire with extra features, the Savvywire, can be used. All of these wires work well, are safe, and are already used in daily medical practice. Researchers will compare these LV-guidewires to see if the Savvywire adds additional value.
Patients aged 50 or older who undergo a TAVI procedure via the femoral artery (blood vessel in the groin) can participate. Participants will receive the usual care and standard follow-up, only their data will be collected and analyzed.
详细描述
Patients are asked for consent after the TAVI procedure. Procedural data is therefore collected retrospectively, while standard follow-up data (3 months after the procedure) is collected prospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •Accepted for transfemoral TAVI procedure by Heart team and TAVI team
- •Transfemoral TAVI procedure with balloon-expandable or self-expandable TAVI platform
- •Ability to understand and the willingness to provide written informed consent
- •Patients scheduled for valve-in-valve procedures can be included
- •Patients with bicuspid anatomy can be included
排除标准
- •Patients planned for a non-transfemoral TAVI procedure
- •Extremely horizontal aorta (aortic root angle >70 degrees)
- •Extreme tortuosity at the level of the iliofemoral arteries, abdominal and/or thoracic aorta
- •Inability to provide informed consent.
研究组 & 干预措施
SavvyWire
TAVI procedures in which the SavvyWire is used as LV-guidewire.
Other LV-guidwire
TAVI procedures in which another LV-guidewire (i.e. Confida or Safari) is used.
结局指标
主要结局
Register which TAVI LV-guidewires are used in contemporary practice
时间窗: At enrollment
Register which type of TAVI LV-guidewire is used during the TAVI procedure (SavvyWire, Safari, Confida etc).
To register LV-aortic pressure gradients (mmHg) during each procedural step in the SavvyWire group.
时间窗: Collected during TAVI procedure, extracted at enrollment
With the SavvyWire, continuous hemodynamic pressure measurements can be performed during the procedure in the aorta and the left ventricle. Pressure measurements (mmHg) during the following procedural steps will be collected: baseline, pacing during predilatation, after predilatation, pacing during TAVI deployment, after TAVI deployment, after equilibration and drift check, after possibele postdilatation.
To correlate hemodynamic pressure gradient after each procedural step (predilatation, 80% TAVI deployment, postdilatation) to standard baseline CT assessment of valvular calcifications
时间窗: At enrollment
Performance of the SavvyWire as LV-guidewire for TAVI device placement
时间窗: At enrollment + after 3 months of standard follow-up
Based on: guidewire kink yes/no, procedural success, complications during and after TAVI procedure and after standard 3 months follow-up (vascular complication, coronary obstruction, conversion to sternotomy, pacemaker, cva, mortality)
Performance of the SavvyWire in hemodynamic guidance
时间窗: At enrollment
Based on: succesfull hemodynamic registrations, drift check (delta between aortic pressure measurement of Savvywire and standard pigtail in aorta used during TAVI procedure), more postdilatation in Savvywire group compared to regular LV guidewire group.
Pacing performance of the SavvyWire
时间窗: At enrollment
Based on: pacing frequency, loss-of-capture, the need for RV pacing
To investigate the potential streamlining effect of the SavvyWire on TAVI workflow
时间窗: At enrollment
Based on: skin-to-skin time, total contrast volume (mL), amount of radiation exposure (total DAP, total Air Kerma)
次要结局
未报告次要终点
研究者
dr Pim A.L. Tonino
Prof. Pim A.L. Tonino, MD, PhD
Catharina Ziekenhuis Eindhoven