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

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

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Bicuspid-related Aortopathy Aortic Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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TAVI patients with native BAV

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

CT follow-up

Intervention Type DIAGNOSTIC_TEST

Computed tomography angiography assessment of BAV-related aorthopathy

Interventions

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CT follow-up

Computed tomography angiography assessment of BAV-related aorthopathy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No