NCT05491070

Brief Summary

Femoral artery approach for transcatheter aortic valve implantation (TAVI) is an ideal approach site. However the closure for femoral artery after transfemoral TAVI is challenging. We aimed to compared the efficacy and safety of Angio-Seal + Proglide vs. Dual Proglide for femoral arteriotomy closure following TAVI

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 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

March 20, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2018

Completed
4.1 years until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

September 23, 2024

Status Verified

October 1, 2023

Enrollment Period

5.1 years

First QC Date

July 20, 2018

Last Update Submit

September 18, 2024

Conditions

Aortic Valve StenosisTranscatheter Aortic Valve Implantation

Outcome Measures

Primary Outcomes (3)

  • Vascular complication

    TAVI related major or minor vascular complication according to valve academic research consortium 3 criteria

    during hospitalization for index procedure

  • Life threatening bleeding complication

    TAVI related life threatening bleeding according valve academic research consortium 3 criteria

    within 24hrs after the index procedure

  • Major or minor bleeding complication without life threatening condition

    TAVI related major or minor bleeding according valve academic research consortium 3 without life threatening condition

    within 24hrs after the index procedure

Secondary Outcomes (3)

  • Bail-out closure device use

    within 10mins after the index procedure

  • Limb ischemia related to TAVI

    within one year after TAVI

  • In-hospital serious vascular complications requiring percutaneous or surgical interventions

    In the index hospitalization (up to 14 days)

Study Arms (2)

Dual Proglide

EXPERIMENTAL

Use Two Progilde for closure of femoral artery with large sheath in transfemoral TAVI

Device: Vascular closure device (Angio-Seal, Progilde)

Progilde + AngioSeal

EXPERIMENTAL

Use Progilde + AngioSeal for closure of femoral artery with large sheath in transfemoral TAVI

Device: Vascular closure device (Angio-Seal, Progilde)

Interventions

Vascular closure device (Angio-Seal, Progilde)DEVICE

In transfemoral TAVI, vascular closure devices were used for femoral artery wound closure, progilde and angio-seal can be used in wound closure. We aimed to compared the efficacy and safety of different vascular closure device in TAVI

Dual ProglideProgilde + AngioSeal

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 20 years old
  • Severe aortic stenosis and suitable candidate for transfemoral transcatheter aortic valve implantation

You may not qualify if:

  • Age \< 20 years old
  • Severe aortic stenosis not suitable for transfemoral transcatheter aortic valve implantation
  • An initial plan for a surgical transfemoral cut-down approach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • Yeh CF, Kao HL, Ko TY, Chen CK, Tsai CH, Huang CC, Chen YH, Chan CY, Lin MS. Dual ProGlide vs ProGlide and Angio-Seal for Femoral Access Hemostasis After Transcatheter Aortic Valve Replacement: A Randomised Comparative Trial. Can J Cardiol. 2025 Jan;41(1):12-20. doi: 10.1016/j.cjca.2024.09.001. Epub 2024 Sep 6.

    PMID: 39245341DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Vascular Closure Devices

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Mao-Shin Lin, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2018

First Posted

August 8, 2022

Study Start

March 20, 2018

Primary Completion

April 13, 2023

Study Completion

April 30, 2024

Last Updated

September 23, 2024

Record last verified: 2023-10

Locations

TW(1)