PRogression Of bicuSPid-rElated aoRtOpathy in Patients Undergoing Transcatheter Aortic Valve Implantation (PROSPERO-TAVI)

NCT06248294 | Unknown DMC

• 1 other identifier: UCatania003
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Transcatheter aortic valve implantation (TAVI) is being offered to younger patients affected by severe aortic stenosis as an alternative to surgery. Although historically excluded from the main randomized clinical trials, patients with native bicuspid aortic valve (BAV) are commonly treated in daily TAVI practice. Indeed, several observational studies reported similar outcomes of TAVI in BAV patients compared to tricuspid aortic valve (TAV) patients. Notably, BAV is frequently associated with aortic dilatation (20% to 84% of BAV patients). Surgical patients usually undergo concomitant aortic root replacement if aortic diameter exceed 50 mm (5). TAVI patients do not undergo treatment of the concomitant aortopathy, but currently there is a paucity of data regarding the progression of the aortopathy after AS treatment (6,7). The main aim of this ambispective, multicenter study is to evaluate the progression of the bicuspid valve-associated aortopathy in patients undergoing TAVI by computed tomography angiography (CTA) assessment at follow-up.

Conditions

Bicuspid-related Aortopathy; Aortic Stenosis

Keywords

BAV; TAVI; Aortopathy

Outcome Measures

Primary Outcomes (1)

• Absolute difference in maximum aortic diameters at multiple levels of ascending aorta

  Measurements of maximum aortic diameters at follow-up CTA assessment will be compared with values at pre-TAVI CTA assessment

  5 years

Secondary Outcomes (3)

• Death, stroke or rehospitalization for heart failure

  5 years

• Aortic events leading to urgent intervention or elective aortic root replacement

  5 years

• Bioprosthesis dysfunction (HALT or RLM at 4-D CTA assessment)

  5 years

Study Arms (1)

TAVI patients with native BAV

Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve

Diagnostic Test: CT follow-up

Interventions

CT follow-up DIAGNOSTIC_TEST

Computed tomography angiography assessment of BAV-related aorthopathy

TAVI patients with native BAV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing TAVI for severe aortic stenosis and native bicuspid aortic valve

You may qualify if:

• Patients undergoing TAVI with native BAV from January 2018 to December 2019

You may not qualify if:

• Patients undergoing TAVI without native BAV
• Patients receiving first generation TAVI device
• Patients undergoing TAVI before January 2018 or after December 2019

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico - San Marco

Catania, 95123, Italy

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Giuliano Costa, MD

CONTACT

3934721874329; giulianocosta90@gmail.com

Marco Barbanti, MD

CONTACT

393283026464; mbarbanti83@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: February 8, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

IT (1)