NCT04632641View on ClinicalTrials.gov

Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial

NACompletedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

April 23, 2021

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2023

Conditions
Atrial FibrillationAtrial FlutterHeart BlockPulmonary Embolism and ThrombosisMitral Valve RepairSinus Node DysfunctionBradycardiaBrady-tachy Syndrome
Interventions
DEVICE

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

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.

OTHER

Figure 8 Suture - LARGE-BORE PROCEDURES

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

Trial Locations (1)

53215

Aurora St. Luke's Medical Center, Milwaukee

All Listed Sponsors
lead

Wake Forest University Health Sciences

OTHER