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

Sponsor

Delray Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04831008

Collaborator

Florida Atlantic University (Other)

Enrollment

Location

Arms

27.8

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Venous Puncture	Other: Figure-of-eight suture Other: Perclose Device	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 6, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Figure-of-eight Using the figure-of-eight closure technique when closing access for structural heart therapies.	Other: Figure-of-eight suture Using the figure-of-eight closure technique when closing access for structural heart therapies.
Active Comparator: Perclose Device Using the Perclose device when closing access for structural heart therapies.	Other: Perclose Device Using the Perclose device when closing access for structural heart therapies.

Arm

Intervention/Treatment

Active Comparator: Figure-of-eight

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

Other: Figure-of-eight suture

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

Active Comparator: Perclose Device

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

Other: Perclose Device

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Delray Medical Center	Delray Beach	Florida	United States	33484

Sponsors and Collaborators

Delray Medical Center
Florida Atlantic University

Investigators

Principal Investigator: Houman Khalili, MD, Delray Medical Center
Principal Investigator: Brijeshwar Maini, Delray Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Houman Khalili MD, Principal Investigator, Delray Medical Center

ClinicalTrials.gov Identifier:

NCT04831008

Other Study ID Numbers:

2020-149

First Posted:

Apr 5, 2021

Last Update Posted:

Aug 19, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Houman Khalili MD, Principal Investigator, Delray Medical Center

Perclose Device

Figure-of-eight suture

Study Results

No Results Posted as of Aug 19, 2021