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

Delray Medical Center

Status: Completed

Conditions: Venous Puncture

Treatments: Other: Figure-of-eight suture; Other: Perclose Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04831008

2020-149

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Figure-of-eight

Active Comparator group

Description:

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

Treatment:

Other: Figure-of-eight suture

Perclose Device

Active Comparator group

Description:

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

Treatment:

Other: Perclose Device