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Completed

NCT Number: NCT04831008

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

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

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Key information

Conditions

Venous Puncture

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Delray Medical Center

Delray Beach, Florida, 33484, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Figure-of-eight suture

Other

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

Perclose Device

Other

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

Primary outcomes

  1. Hemostasis Time

    Time frame: Immediate

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

  2. Procedure Time

    Time frame: Immediate

  3. Access Site Complication

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Delray Medical Center

Other

Collaborators

  • Florida Atlantic University

Registry information

Official study title

Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2021
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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