Clinical trial NCT05637983: Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)
Official title: Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcatheter Aortic Valve Replacement
Lead sponsor: Fondazione Toscana Gabriele Monasterio
Sponsor class: OTHER
Collaborators: name: Nicolaus Copernicus University
First posted: 2022-12-06
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomized trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite of CV mortality, vascular complications or access-related bleeding after TAVR at 30 days.
timeFrame: 1 month
Secondary outcomes:
measure: CV mortality
timeFrame: 1 month
measure: Vascular complications
timeFrame: 1 month
measure: Life-threatening or disabling bleeding
timeFrame: 1 month
measure: Major bleeding (BARC type 3a)
timeFrame: 1 month
measure: Major vascular complications
timeFrame: 1 month
measure: Minor vascular complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Massa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio
state: MS
Study officials:
affiliation: Fondazione Toscana Gabriele Monasterio
name: Sergio Berti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nicolaus Copernicus University
name: Eliano Navarese
role: PRINCIPAL_INVESTIGATOR
References: