NCT05739253

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

February 12, 2023

Last Update Submit

February 6, 2025

Conditions

Aortic StenosisAscending Aortic DilatationBicuspid Aortic Valve

Keywords

Transcatheter aortic valve replacementAscending aortic diameterAscending aortic dilatationBicuspid aortic valve

Outcome Measures

Primary Outcomes (1)

  • Rate of ascending aortic dilatation

    The change of AA diameters (before the procedure and at the latest follow-up) divided by the follow-up period.

    1-year and 2-year

Secondary Outcomes (2)

  • Rate of all-cause mortality

    1-year and 2-year

  • Rate of adverse aortic events

    1-year and 2-year

Study Arms (1)

Transfemoral TAVR for AS

Patients undergoing transfemoral transcatheter aortic valve replacement for aortic stenosis

Procedure: Transcatheter aortic valve replacement

Interventions

Transcatheter aortic valve replacementPROCEDURE

All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis

Transfemoral TAVR for AS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The indication to perform transcatheter aortic valve replacement was based on a consensus by the Institutional Heart Team.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (1)

  • An K, Zhang F, Ouyang W, Pan X. Blood flow dynamics in the ascending aorta of patients with bicuspid aortic valve before and after transcatheter aortic valve replacement: a computational fluid dynamics study. BMC Cardiovasc Disord. 2024 Dec 20;24(1):717. doi: 10.1186/s12872-024-04394-w.

    PMID: 39702010DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisBicuspid Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Central Study Contacts

Xiangbin Pan, Dr

CONTACT

0086-010-88396666panxiangbin@fuwaihospital.org

Kang An, Dr

CONTACT

0086-15801301740ankang913@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 22, 2023

Study Start

March 22, 2022

Primary Completion

March 21, 2025

Study Completion

March 21, 2025

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)