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

Delray Medical Center50 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Venous Puncture

Interventions

Figure-of-eight sutureOTHER

Using the figure-of-eight closure technique when closing access for structural heart therapies.

Perclose DeviceOTHER

Using the Perclose device when closing access for structural heart therapies.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Delray Medical Center

Delray Beach, Florida, United States

Outcomes

Primary Outcomes

Hemostasis Time

To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access

Time frame: Immediate

Procedure Time

Time frame: Immediate

Access Site Complication

Time frame: 1 month

Data from ClinicalTrials.gov

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