Outcomes for Patients With Ascending Aortic Dilation Who Underwent TAVR

NCT07148973 | Completed DMC

• 1 other identifier: 2021062
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transcatheter Aortic Valve Replacement (TAVR); Ascending Aortic Dilation

Outcome Measures

Primary Outcomes (2)

• All-Cause Mortality

  6 month

• Mortality

  6 month

Study Arms (1)

AAD

Procedure: Transcatheter Aortic Valve Replacement

Interventions

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.

AAD

Eligibility Criteria

• Age: 50 Years - 93 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who were diagnosed with severe AS via the TAVR procedure using a self-expanding valve (Venus-A valve, Qiming Med Tech Inc., Hangzhou, China) between January 2019 and July 2021 at our Heart Center were retrospectively enrolled.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• zjq: lead

Study Sites (1)

the Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

Location

MeSH Terms

Conditions

Aneurysm, Ascending Aorta

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: January 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

CN (1)