NCT05836311

Brief Summary

This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

April 13, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 19, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2025

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

April 13, 2023

Last Update Submit

May 2, 2023

Conditions

Aortic Valve StenosisStructural Valve DeteriorationStructural Valve Degeneration

Keywords

Residual Stenosis

Outcome Measures

Primary Outcomes (2)

  • SAFETY:Incidence of Intrahospital Major Vascular Complications and Bleeding type 2 or type >2 (according to VARC 3 criteria)

    Intrahospital Major Vascular Complications and Bleeding type 2 or type \>2 (according to VARC 3 criteria)

    30 days

  • EFFICACY:Incidence of successful femoral closure

    Complete hemostasis at the puncture site with manual compression after the initial perclosure strategy

    30 days

Secondary Outcomes (5)

  • Cost-effectiveness evaluation

    30 days

  • Incidence of vascular complications (according to VARC3 criteria)

    30 days

  • Incidence of bleeding (according to VARC3 criteria)

    30 days

  • All-cause Mortality

    30 days

  • All-cause Mortality

    1 year

Study Arms (2)

Patients treated with one Perclose Proglide

Patients undergoing transfemoral TAVI implantation treated with one Perclose Proglide Suture

Device: One Perclose Proglide Suture

Patients treated with two Perclose Proglide Suture

Patients undergoing transfemoral TAVI implantation treated with two Perclose Proglide Suture

Device: Two Perclose Proglide Suture

Interventions

One Perclose Proglide SutureDEVICE

One Perclose Proglide Suture

Patients treated with one Perclose Proglide
Two Perclose Proglide SutureDEVICE

One Perclose Proglide Suture

Patients treated with two Perclose Proglide Suture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing transfemoral TAVI implantation in a single center

You may qualify if:

  • Patients older than 18 years
  • Patients who have undergone Transfemoral TAVI implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Related Publications (2)

  • Kodama A, Yamamoto M, Shimura T, Kagase A, Koyama Y, Tada N, Takagi K, Araki M, Yamanaka F, Shirai S, Watanabe Y, Hayashida K. Comparative data of single versus double proglide vascular preclose technique after percutaneous transfemoral transcatheter aortic valve implantation from the optimized catheter valvular intervention (OCEAN-TAVI) japanese multicenter registry. Catheter Cardiovasc Interv. 2017 Sep 1;90(3):E55-E62. doi: 10.1002/ccd.26686. Epub 2016 Oct 27.

    PMID: 27785881BACKGROUND

  • Bazarbashi N, Ahuja K, Gad MM, Sammour YM, Kaur M, Karrthik A, Saad AM, Khubber S, Dhaliwal K, Mick SL, Navia JL, Puri R, Reed GW, Krishnaswamy A, Kapadia SR. The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center. Catheter Cardiovasc Interv. 2020 Aug;96(2):442-447. doi: 10.1002/ccd.28585. Epub 2019 Nov 12.

    PMID: 31713996BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

VICENTE SERRA GARCIA, MD, PhD

CONTACT

0034932746155vctsrr@hotmail.com

BRUNO GARCIA DEL BLANCO, MD, PhD

CONTACT

0034932746155brunogb51@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 1, 2023

Study Start

July 19, 2023

Primary Completion

February 19, 2025

Study Completion

February 19, 2025

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)