NCT05637983

Brief Summary

Recent observational data showed a marked reduction of vascular and bleeding complications by the use of ultrasound(US)-guided femoral artery puncture to gain the vascular access and guide the implantation of the Perclose ProGlide® vascular closure system. We aimed to compare in a 1:1 randomized fashion the effect of US-guided femoral puncture and Perclose ProGlide® implantation optimization vs fluoroscopy-guided puncture followed by Perclose ProGlide/ ProStyle implantation (standard approach) during TAVR.

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
508

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

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

Study Start

First participant enrolled

July 4, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 6, 2022

Status Verified

November 1, 2022

Enrollment Period

1.3 years

First QC Date

November 25, 2022

Last Update Submit

November 25, 2022

Conditions

Transcatheter Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

  • Composite of CV mortality, vascular complications or access-related bleeding after TAVR at 30 days.

    1 month

Secondary Outcomes (6)

  • CV mortality

    1 month

  • Vascular complications

    1 month

  • Life-threatening or disabling bleeding

    1 month

  • Major bleeding (BARC type 3a)

    1 month

  • Major vascular complications

    1 month

  • +1 more secondary outcomes

Study Arms (2)

US-guided femoral puncture

EXPERIMENTAL

US-guided femoral puncture and Perclose ProGlide/Prostyle implantation during transcatheter aortic valve replacement (TAVR)

Procedure: US-guided femoral puncture vs Fluoroscopy-guided puncture

Fluoroscopy-guided puncture

ACTIVE COMPARATOR

Fluoroscopy-guided puncture and Perclose ProGlide/Prostyle implantation during transcatheter aortic valve replacement (TAVR)

Procedure: US-guided femoral puncture vs Fluoroscopy-guided puncture

Interventions

US-guided femoral puncture vs Fluoroscopy-guided puncturePROCEDURE

US-guided femoral puncture and Perclose ProGlide®/Prostyle implantation compared to Fluoroscopy-guided puncture and Perclose ProGlide®/Prostyle in TAVR

Fluoroscopy-guided punctureUS-guided femoral puncture

Eligibility Criteria

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

You may qualify if:

  • Eligible Patients are male or female with severe aortic stenosis evaluated by the Heart Team as candidate to TAVR based on the current cardiology guidelines.

You may not qualify if:

  • Refusal to participate in the study;
  • Inability to provide written consent to the study protocol;
  • Chronic immuno-suppressant therapy;
  • Any concomitant condition which, in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological disorder);
  • Enrolment in another study that could confound the results of this study;
  • Life expectancy \< 1 year;
  • Any contraindication to TAVR procedure;
  • Non transfemoral TAVR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Toscana Gabriele Monasterio

Massa, MS, 54100, Italy

RECRUITING

Related Publications (1)

  • Strauss SA, Ma GW, Seo C, Siracuse JJ, Madassery S, Truesdell AG, Pereira K, Korngold EC, Kayssi A. Ultrasound-guided versus anatomic landmark-guided percutaneous femoral artery access. Cochrane Database Syst Rev. 2025 Mar 28;3(3):CD014594. doi: 10.1002/14651858.CD014594.pub2.

    PMID: 40152297DERIVED

Study Officials

  • Sergio Berti, MD

    Fondazione Toscana Gabriele Monasterio

    PRINCIPAL INVESTIGATOR

  • Eliano Navarese

    Nicolaus Copernicus University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Berti, MD

CONTACT

3488964831berti@ftgm.it

Eliano Navarese, MD

CONTACT

3342594725elianonavarese@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Cardiac Diagnostic and Interventional Unit

Study Record Dates

First Submitted

November 25, 2022

First Posted

December 6, 2022

Study Start

July 4, 2022

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

December 6, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)