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

Fondazione Toscana Gabriele Monasterio

Status: Enrolling

Conditions: Transcatheter Aortic Valve Replacement

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05637983

Versione: 1.0 del 18/06/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 508 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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508 participants in 2 patient groups

US-guided femoral puncture

Experimental group

Description:

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

Treatment:

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

Fluoroscopy-guided puncture

Active Comparator group

Description:

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

Treatment:

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