NCT04904809

Brief Summary

The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

May 18, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 20, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

May 18, 2021

Results QC Date

May 26, 2023

Last Update Submit

July 19, 2023

Conditions

Arrhythmia

Keywords

ABT-CIP-10410AblationDUSFemoral DUS

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With Major Vascular Complications by DUS Detection at Discharge

    Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization.

    Within 24 hours of procedure.

  • Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge

    Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications.

    Within 24 hours of procedure.

Study Arms (1)

All Registered Patients

EXPERIMENTAL

All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System.

Device: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System

Interventions

Perclose ProGlide SMC System and/or Perclose ProStyle SMCR SystemDEVICE

The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.

Also known as: Perclose ProStyle SMCR System
All Registered Patients

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein
  • All the access sites are planned to be treated with Perclose SMC
  • Written informed consent is obtained prior to the procedure

You may not qualify if:

  • Visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure
  • Prior ipsilateral deep vein thrombosis within 6 months
  • International Normalization Ratio \>3.5 for patients on warfarin
  • Subject who is not able to ambulate pre-procedure
  • Women who are pregnant (based on site standard pre-procedure pregnancy test)
  • Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Sandeep Pingle
Organization
Abbott Vascular
sandeep.pingle1@abbott.com
858-222-9673

Study Officials

  • Sanjaya K Gupta, MD

    St. Luke's Hospital

    PRINCIPAL INVESTIGATOR

  • Soroosh Kiani, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 27, 2021

Study Start

September 1, 2021

Primary Completion

May 27, 2022

Study Completion

May 27, 2022

Last Updated

July 20, 2023

Results First Posted

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)