Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement

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

RECRUITING

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-22

Study Completion Date

2025-03-21

Brief Summary

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The goal of this observational study is to assess the changes of ascending aortic diameter in patients undergoing transcatheter aortic valve replacement. The main questions it aims to answer are:

1. whether the ascending aortic diameter increases or remains stable after transcatheter aortic valve replacement, especially in patients with preoperative ascending aortic dilatation;
2. the determinants of postoperative ascending aortic dilatation.

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Detailed Description

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Ascending aortic (AA) dilatation occurs frequently in patients with aortic stenosis (AS). For patients who are candidates for transcatheter aortic valve replacement (TAVR), simultaneous repair of a dilatated AA is technically difficult. As the indications for TAVR have extended to low-risk patients and patients with bicuspid aortic valve , AA dilatation should be considered as a new criterion to refine risk stratification in patients undergoing TAVR. In this observational study, we aim to evaluate the changes of AA diameters and identify the determinants post-TAVR AA dilatation.

Conditions

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Aortic Stenosis Ascending Aortic Dilatation Bicuspid Aortic Valve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transfemoral TAVR for AS

Patients undergoing transfemoral transcatheter aortic valve replacement for aortic stenosis

Transcatheter aortic valve replacement

Intervention Type PROCEDURE

All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis

Interventions

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Transcatheter aortic valve replacement

All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Severe aortic stenosis defined as an aortic valve area of 1cm2 or less or an indexed aortic valve area of 0.6cm2/m2 or less;
* Presence of clinical symptoms defined as a New York Heart Association functional class of 2 or more;
* High risk of surgical aortic valve replacement;
* Suitability for a transfemoral vascular access.

Exclusion Criteria

* Dominant aortic regurgitation;
* History of surgical or transcatheter aortic valve replacement;
* History of aortic surgery;
* Connective tissue disorders.

Eligible Sex

ALL

Accepts Healthy Volunteers

No