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

NCT ID: NCT04831008

Last Updated: 2023-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-06

Study Completion Date

2022-12-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Venous Puncture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Figure-of-eight

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

Group Type ACTIVE_COMPARATOR

Figure-of-eight suture

Intervention Type OTHER

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

Perclose Device

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

Group Type ACTIVE_COMPARATOR

Perclose Device

Intervention Type OTHER

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

Interventions

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Figure-of-eight suture

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

Intervention Type OTHER

Perclose Device

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Florida Atlantic University

OTHER

Sponsor Role collaborator

Delray Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Houman Khalili MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Houman Khalili, MD

Role: PRINCIPAL_INVESTIGATOR

Delray Medical Center

Brijeshwar Maini

Role: PRINCIPAL_INVESTIGATOR

Delray Medical Center

Locations

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Delray Medical Center

Delray Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2020-149

Identifier Type: -

Identifier Source: org_study_id

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