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Comparison of a Single Versus Double Perclose Technique for TAVR

Study acronym: Single
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Start date pushed from Oct 20, 2023 to Jan 23, 2024 Show 6 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Apr 30, 2026 to Feb 13, 2026
    • Study completion date changed from estimate of Jun 28, 2026 to Mar 19, 2026
    • Study description revised
    • Site details revised at 25 of 25 sites
    • Eligibility criteria expanded, about 2 words
  2. Notable Changed Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University to Second Affiliated Hospital, Zhejiang University, School of Medicine
  3. Minor Study sites: 1 to 25
    • Primary completion date: Jan 30, 2026 to Apr 30, 2026
    • Study completion date: Feb 28, 2026 to Jun 28, 2026
    v4
  4. Notable Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 878 to 876
    • Site details revised
    v3
  5. Notable Primary completion date: Nov 15, 2024 to Jan 30, 2026v2 Show 4 more changesShow less
    • Enrollment target: 786 to 878
    • Study completion date: Dec 30, 2025 to Feb 28, 2026
    • Start date: Oct 27, 2023 to Oct 20, 2023
    • Study description shortened, about 1 word
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06173115
Lead Sponsor Second Affiliated Hospital, Zhejiang University, School of Medicine
Conditions
(from sponsor)
Severe Aortic Stenosis
Related terms Aortic Valve Stenosis
Enrollment 876 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov