Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure

Not Applicable

Completed

• Conditions: Venous Puncture
• Interventions: Other: Perclose Device; Other: Figure-of-eight suture

• Registration Number: NCT04831008
• Lead Sponsor: Delray Medical Center

Brief Summary

The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.

Detailed Description

Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.

Study Timeline

• Study Start: 2020-08-06
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.

Exclusion Criteria

• Patients who do not consent
• Minors or those unable to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perclose Device	Perclose Device	Using the Perclose device when closing access for structural heart therapies.
Figure-of-eight	Figure-of-eight suture	Using the figure-of-eight closure technique when closing access for structural heart therapies.

Primary Outcome Measures

Name	Time	Method
Hemostasis Time	Immediate	To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access
Procedure Time	Immediate
Access Site Complication	1 month

Trial Locations

Locations (1)

Delray Medical Center; 🇺🇸 Delray Beach, Florida, United States