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Outcomes for Patients With Ascending Aortic Dilation Who Underwent TAVR

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Status

Completed

Conditions

Ascending Aortic Dilation
Transcatheter Aortic Valve Replacement (TAVR)

Treatments

Procedure: Transcatheter Aortic Valve Replacement

Study type

Observational

Funder types

Other

Identifiers

NCT07148973
2021062

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

50 to 93 years old

Volunteers

No Healthy Volunteers

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.

Trial design

101 participants in 1 patient group

AAD
Treatment:
Procedure: Transcatheter Aortic Valve Replacement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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