SEAL-TAVI - Suture vs combinEd Closure strAtegies in Large-bore Access After TAVI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 705
- 试验地点
- 1
- 主要终点
- Access Site-Related Vascular Complications
研究概览
简要总结
The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral access).
The main questions it aims to answer are:
Does using a single suture device lower the rate of access-related vascular complications compared to using a hybrid combination of a suture device and a plug-based closure device? How do the two closure strategies compare regarding bleeding complications, procedure time, and time to complete vessel sealing?
Researchers will compare a single-suture closure strategy to a hybrid closure strategy (one suture plus one plug-based device) to see if using a single suture reduces vessel-related complications and improves patient safety after TAVI.
Participants will:
Undergo standard pre-procedure screening and TAVI via the main artery in the leg as part of routine medical care.
Receive an initial single-suture placement before the large TAVI delivery system is inserted.
Be evaluated after sheath removal for initial bleeding control; qualifying participants will then be randomly assigned (1:1) to either receive no additional device (single suture group) or receive a plug-based closure device (hybrid group).
Have their heart and access site monitored during hospitalization, including laboratory checks and imaging prior to discharge.
Complete a 72-hour safety and complication evaluation.
详细描述
Large-bore arterial access (≥14 Fr) is a prerequisite for transfemoral transcatheter aortic valve implantation (TF-TAVI). While primary procedural success of TAVI has increased substantially, access site-related vascular and bleeding complications remain a major source of post-procedural morbidity, prolonged hospital stay, and mortality. Standard vascular closure strategies historically relied on dual suture-based vascular closure devices (VCDs). However, mechanical constraints such as subcutaneous suture entanglement, tissue tearing, or inappropriate knot closure may compromise the efficacy of dual-suture techniques.
The SEAL-TAVI trial is an investigator-initiated, prospective, multicenter randomized controlled trial designed to evaluate the safety and efficacy of a standardized single-suture pre-close strategy versus a hybrid strategy (single suture combined with an extravascular plug-based VCD) for primary access site management in an all-comer TF-TAVI population.
Procedural & Randomization Protocol
All enrolled patients undergo TAVI via transfemoral access according to established local clinical standards. Primary access closure follows a standardized intra-procedural common pathway:
Pre-Close Pathway: Under ultrasound guidance, femoral artery puncture is performed, and a single suture-based VCD is placed prior to insertion of the large-bore sheath.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Due to the nature of the intra-operative vascular closure procedure, the operator (Investigator) and immediate interventional team (Care Providers) cannot be masked to device assignment during the TAVI procedure.
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
- •Patient is at least 18 years of age at the time of screening.
- •Patient is scheduled to undergo elective transcatheter aortic valve implantation (TAVI) via transfemoral arterial access.
- •Patient is deemed suitable for transfemoral TAVI and large-bore vascular access closure by the local Heart Team.
- •Patient (or legally authorized representative) provides written informed consent prior to initiating any study-related procedures.
- •Patient is willing and able to comply with all specified study procedures, follow-up visits, and clinical evaluations.
排除标准
- •Planned TAVI procedure via non-femoral arterial access (e.g., transapical, transaortic, subclavian/axillary, or carotid access).
- •Emergency or non-elective TAVI procedure.
- •Target main femoral artery vessel diameter, calcification, or tortuosity judged unsuitable for standard percutaneous large-bore vascular closure device deployment.
- •Known active, unresolved local or systemic infection at the planned vascular access site.
- •Known severe allergy or hypersensitivity to bovine tissue, collagen, or any component of the study closure devices (Perclose ProGlide/ProStyle or Angio-Seal) that cannot be adequately premedicated.
- •Severe bleeding diathesis, active major bleeding, or absolute contraindication to standard periprocedural anticoagulation or antiplatelet therapy.
- •Concurrent participation in another interventional clinical trial investigating cardiovascular devices or drugs that could confound study endpoints.
- •Patient is pregnant or breastfeeding.
- •Patient belongs to a vulnerable population (e.g., individuals deprived of liberty, under guardianship, or unable to give informed consent).
结局指标
主要结局
Access Site-Related Vascular Complications
时间窗: 30 days post-procedure
Composite of major or minor access site-related vascular complications, defined and adjudicated according to the Valve Academic Research Consortium-3 (VARC-3) criteria.
次要结局
- Access Site-Related Bleeding Events(30 days post-procedure)
- Technical and Procedural Success of Vascular Closure(Intra-procedure)
- Time to Access Site Haemostasis(Intra-procedure)
- All-Cause and Cardiovascular Mortality(30 days post-procedure)