Clinical trial NCT06173115: Comparison of a Single Versus Double Perclose Technique for TAVR
Official title: The Utilization of Single Versus Double Perclose Devices for Transfemoral Aortic Valve Replacement Access Site Closure: A Prospective, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Aortic Stenosis
Keywords: transcatheter aortic valve replacement
vascular closure devices
randomized control trial
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 876
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis. It has been proven to be a safe and effective option for patients who are at low, intermediate, and prohibitive risk for surgical valve replacement.

One of the critical components of procedural success in a transfemoral approach is access site management, as vascular complications strongly correlate with adverse outcomes. When major vascular complications occur, there are higher rates of major bleeding, transfusions, and renal failure requiring dialysis, as well as a significantly higher rate of 30-day and 1-year mortality. In recent years, a "preclosure" technique has emerged as a common vascular closure approach using a Perclose Proglide system (Abbott Vascular), in which sutures are deployed before dilating the arterial access site. This allows for arterial closure after dilation to sizing up to larger bore access sheaths that accommodate valve delivery systems. The sutures are subsequently harvested and tightened to close the large bore arteriotomy site at the end of the case. It has been demonstrated that the use of two Perclose devices, or double Perclose closure, is an effective closure technique with a low rate of vascular complications. A large number of TAVR centers have adopted this method for large-bore vascular closure. In the past, there have been few investigations comparing the utilization of a single Perclose device compared to a double Perclose technique. There are numerous theoretical advantages to the use of a single device, which include decreased procedural cost and procedural time. The investigation aimed to determine if there are clinical benefits as well using the single Perclose approach.

Detailed description: SINGLE-CLOSURE (The utilization of Single versus double perclose devices for transfemoral aortIc valve replacement access site Closure) is an investigator-initiated, open-label, multicenter, randomized controlled trial. The study was approved by the local ethics committees of all participating centers, and each patient provided written informed consent for inclusion in the trial. Data management and analysis was performed by an independent data coordinating center, with oversight from a steering committee. The members of the steering committee had full access to the data and vouch for the accuracy and complete- ness of the data and the analyses. The data that support the findings of this study are available from the corresponding author on reasonable request. Patients scheduled to undergo transfemoral TAVR were considered for inclusion in the trial if they met all inclusion and none of the exclusion criteria. Inclusion criteria were an indication for TAVR as judged by the local heart team; selection of the transfemoral access route and a commercially available transcatheter aortic valve; and willingness to comply with protocol specified follow-up evaluations. Principal exclusion criteria were a vascular access site anatomy not suitable for percutaneous vascular closure and the occurrence of vascular access site complications before the TAVR procedure. Additional exclusion criteria were a known allergy or hypersensitivity to any VCD component; unstable active bleeding or bleeding diathesis or significant unman-ageable anemia; absence of computed tomographic data of the access site before the procedure; systemic infection or a local infection at or near the access site; life expectancy of \<6 months because of noncardiac conditions; patients who cannot adhere to or complete the investigational protocol for any reason; pregnant or nursing patients; and participation in any other interventional trial.

The primary end point of the trial was the rate of access site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-3 criteria. The end point was assessed during index hospitalization. Relationship to the access site was deter- mined according to the site used for the large-bore vascular access sheath.

Secondary end points included the rate of the primary end point at 30 days; components of the primary end point in-hospital and at 30 days; in-hospital and 30-day major and minor vascular complications; unplanned vascular surgery or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site; in-hospital and 30-day access site- or access-related minor, major, and disabling or life threatening bleeding; need for blood transfusion for access site- or access-related bleeding or vascular complications; rate of VCD failure, defined as the failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment (other than manual compression or adjunctive endovascular ballooning); in-hospital and 30-day all-cause death; in-hospital and 30-day death attributed to access site or access-related complications; need and number of additional unplanned VCDs; time to hemostasis, defined as the time from VCD application to complete hemostasis; and the length of postprocedural hospital stay.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo transfemoral TAVR were considered for inclusion in the trial if they met all inclusion and none of the exclusion criteria. Inclusion criteria were an indication for TAVR as judged by the local heart team; selection of the transfemoral access route and a commercially available transcatheter aortic valve; and willingness to comply with protocol specified follow-up evaluations.

Exclusion Criteria:

* Principal exclusion criteria were a vascular access site anatomy not suitable for percutaneous vascular closure and the occurrence of vascular access site complications before the TAVR procedure. Additional exclusion criteria were a known allergy or hypersensitivity to any VCD component; unstable active bleeding or bleeding diathesis or significant unman ageable anemia; absence of computed tomographic data of the access site before the procedure; systemic infection or a local infection at or near the access site; life expectancy of \<6 months because of noncardiac conditions; patients who can-not adhere to or complete the investigational protocol for any reason; pregnant or nursing patients; and participation in any other interventional trial.

Primary outcomes:
measure: The primary end point of the trial was the rate of access site or access-related major and minor vascular complications defined according to the Valve Academic Research Consortium-3 criteria
timeFrame: The end point was assessed during index hospitalization
Secondary outcomes:
measure: The rate of the primary end point at 30 days
timeFrame: 30 days
measure: Components of the primary end point in-hospital and at 30 days
timeFrame: 30 days
measure: In-hospital and 30-day major and minor vascular complications
timeFrame: 30 days
measure: Unplanned vascular surgery or use of endovascular stent or stent-graft or other endovascular interventions at the puncture site
timeFrame: 30 days
measure: in-hospital and 30-day access site- or access-related minor, major, and disabling or life- threatening bleeding; need for blood transfusion for access site or access related bleeding or vascular complications
timeFrame: 30 days
measure: Rate of VCD failure, defined as the failure of a closure device strategy to achieve hemostasis with the need for an alternative treatment (other than manual compression or adjunctive endovascular ballooning)
timeFrame: 30 days
measure: In-hospital and 30-day all-cause death; in-hospital and 30-day death attributed to access site- access-related complications; need and number of additional unplanned VCDs
timeFrame: 30 days
measure: Time to hemostasis, defined as the time from VCD application to complete hemostasis
timeFrame: 30 days
measure: The length of postprocedural hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Department of Cardiology, The Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jianan Wang, PhD
role: STUDY_CHAIR
References: