CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 107 enrolled
Drug / intervention
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04632641
NCT04632641N/ACompleted
CompareCT.gov

Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial: A Randomized, Prospective Study of the Safety and Efficacy of Venous Closure Device Compared to Conventional Closure Strategies in Post Venous Access Procedures

Wake Forest University Health Sciences·interventional·Posted Nov 17, 2020·Updated Oct 3, 2024

In Brief

A clinical study evaluating Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES and Figure 8 Suture - LARGE-BORE PROCEDURES for Atrial Fibrillation and 7 related conditions. Completed, enrolled 107 participants across 1 site.

Detailed Summary

Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures. Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure following venous access procedure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Atrial Flutter, Heart Block, Pulmonary Embolism and Thrombosis, Mitral Valve Repair, Sinus Node Dysfunction, Bradycardia, Brady-tachy Syndrome
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 17, 2020
Enrollment StartApr 23, 2021
Primary CompletionDec 31, 2022
Study CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.6 years ago

Interventions

Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURESdevice

The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.

Figure 8 Suture - LARGE-BORE PROCEDURESother

A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.