Outcomes for Patients With Ascending Aortic Dilation Who Underwent TAVR

The present study was designed to evaluate the safety of TAVR with a preoperative ascending aortic (AA) diameter ≥ 40 mm. This study also aimed to explore the procedural outcomes and clinical prognoses of patients with AAD combined compared to those of patients without AAD combined who underwent TAVR.

Between January 2019 and July 2021, a total of 186 patients who were diagnosed at a single centre with severe AS underwent the TAVR procedure using a self-expanding valve. The AA diameter was evaluated via 3-dimensional (3D) multidetector computed tomography (MDCT) before TAVR. AAD was defined as a value of AAD ≥ 40 mm.

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Key information

Conditions

Transcatheter Aortic Valve Replacement (TAVR) Aneurysm Aneurysm, Ascending Aorta Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Ascending Aortic Dilation Cardiovascular Diseases Vascular Diseases

Age range

50 year–93 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) severe AS patients diagnosed on the recommendation of the European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines (aortic valve area ≤ 1.0 cm²/aortic valve index ≤ 0.6 cm²/m²/peak aortic velocity (Vmax)≥4.0 m/s); (2) patients at intermediate- to high-risk surgical risk or a Society of Thoracic Surgeons risk (STS) score > 4; (4) patients whose anatomy was evaluated by 3-dimensional (3D) multidetector computed tomography (MDCT) appropriate for TAVR; and (4) patients with severe AS with typical symptoms.

Exclusion criteria

(1) patients with active endocarditis, acute aortic dissection, or acute myocardial infarction; (2) patients with expectations of life< 1 year; and (3) patients with inappropriate anatomy evaluated by 3D MDCT.

Treatment and study plan

Transcatheter aortic valve replacement

Procedure

The TAVR surgery mainly involves attaching an artificially-made aortic valve to a special catheter, and then using the catheter to deliver the valve to the affected area and release it. This surgery replaces the original aortic valve with an artificial one, thereby restoring the valve function. Compared with traditional open-chest surgery, it causes less trauma, has lower risks, and enables faster recovery. It is particularly suitable for patients who cannot tolerate open-chest surgery, have poor cardiac function, or are older.

Primary outcomes

All-Cause Mortality

Time frame: 6 month
Mortality

Time frame: 6 month

Sponsors and collaborators

Lead sponsor

zjq

Other

Registry information

Official study title

Outcomes for Patients With Ascending Aortic Dilation Who Underwent Transcatheter Aortic Valve Replacement in a Chinese Population

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Aug 29, 2025
Registry last updated: Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed