NCT04831008

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

March 31, 2021

Last Update Submit

January 9, 2023

Conditions

Venous Puncture

Keywords

Perclose DeviceFigure-of-eight suture

Outcome Measures

Primary Outcomes (3)

  • Hemostasis Time

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

    Immediate

  • Procedure Time

    Immediate

  • Access Site Complication

    1 month

Study Arms (2)

Figure-of-eight

ACTIVE COMPARATOR

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

Other: Figure-of-eight suture

Perclose Device

ACTIVE COMPARATOR

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

Other: Perclose Device

Interventions

Figure-of-eight sutureOTHER

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

Figure-of-eight
Perclose DeviceOTHER

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

Perclose Device

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.

You may not qualify if:

  • Patients who do not consent
  • Minors or those unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Study Officials

  • Houman Khalili, MD

    Delray Medical Center

    PRINCIPAL INVESTIGATOR

  • Brijeshwar Maini

    Delray Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 5, 2021

Study Start

August 6, 2020

Primary Completion

December 13, 2022

Study Completion

December 13, 2022

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

US(1)