Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE

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

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-31

Study Completion Date

2026-08-30

Brief Summary

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This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.

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Detailed Description

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Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS), especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic valve replacement (SAVR), current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.

Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR, simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear. Moreover, there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients. The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.

Conditions

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Aortic Stenosis Ascending Aortic Dilatation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Self-expandable valve group vs. Balloon-expandable valve group

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Surgeons are aware of randomisation results, however, participants and research staff are all blinded to the randomisation schemes.

Study Groups

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Self-expandable valve group

Patients using self-expandable valves

Group Type EXPERIMENTAL

self-expandable valves

Intervention Type DEVICE

patients undergoing TAVR use self-expandable valves

Balloon-expandable valve group

Patients using balloon-expandable valves

Group Type EXPERIMENTAL

balloon-expandable valves

Intervention Type DEVICE

patients undergoing TAVR use balloon-expandable valves

Interventions

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self-expandable valves

patients undergoing TAVR use self-expandable valves

Intervention Type DEVICE

balloon-expandable valves

patients undergoing TAVR use balloon-expandable valves

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Severe aortic stenosis;
* Transfemoral access;
* Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and \<55mm;
* Anticipated life expectancy \>1 year;
* Age ≥ 65 years.

Exclusion Criteria

* Dominant aortic regurgitation,;
* A history of SAVR or TAVR;
* A history of aortic surgery;
* Emergent TAVR.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiangbin Pan, MD

Role: PRINCIPAL_INVESTIGATOR

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