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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

508 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-04

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transcatheter Aortic Valve Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 randomized trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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US-guided femoral puncture

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

Group Type EXPERIMENTAL

US-guided femoral puncture vs Fluoroscopy-guided puncture

Intervention Type PROCEDURE

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

Fluoroscopy-guided puncture

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

Group Type ACTIVE_COMPARATOR

US-guided femoral puncture vs Fluoroscopy-guided puncture

Intervention Type PROCEDURE

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

Interventions

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US-guided femoral puncture vs Fluoroscopy-guided puncture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No