Ultrasound-guided Femoral Puncture to Reduce Access- Related Complications After TAVR: (ACCESS-TAVR SIRIO)
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
Sergio Berti
Director Cardiac Diagnostic and Interventional Unit
Fondazione Toscana Gabriele Monasterio