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Clinical Trials/NCT05637983
NCT05637983RecruitingNot Applicable

Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)

Fondazione Toscana Gabriele Monasterio2 sites in 1 country508 target enrollmentStarted: July 4, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
508
Locations
2
Primary Endpoint
Composite of CV mortality, vascular complications or access-related bleeding after TAVR at 30 days.

Study Overview

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.

Detailed Description

Transfemoral approach has become the standard route for a transcatheter aortic valve replacement (TAVR) procedure. Despite the technology improvements, vascular complications and access-related bleeding are frequently observed after TAVR and emerge predominantly within 30 days after TAVR. 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 1 month

Secondary Outcomes

  • Life-threatening or disabling bleeding(1 month)
  • Major bleeding (BARC type 3a)(1 month)
  • Minor vascular complications(1 month)
  • CV mortality(1 month)
  • Vascular complications(1 month)
  • Major vascular complications(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sergio Berti

Director Cardiac Diagnostic and Interventional Unit

Fondazione Toscana Gabriele Monasterio

Study Sites (2)

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