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Efficacy of Self-expandable and Balloon-expandable Valves in Patients With Ascending Aortic Dilation

NCT ID: NCT06743568

Last Updated: 2024-12-20

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

2024-10-15

Study Completion Date

2027-07-31

Brief Summary

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This study evaluated the efficacy of self-expandable valves and balloon-expandable valves in patients with ascending aortic dilation who undergo transcatheter aortic valve replacement.

Detailed Description

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Ascending aortic dilation (AAD) is a common feature in patients with aortic stenosis, especially in those with bicuspid aortic valve. According to the 2022 AHA/ACC Guideline for the Diagnosis and Management of Aortic Disease, in patients undergoing surgical aortic valve replacement who have a concomitant AAD with a maximum diameter of ≥45mm, ascending aortic replacement is reasonable when performed by experienced surgeons in a Multidisciplinary Aortic Team (Class 2a, Level B-NR). However, in patients undergoing transcatheter aortic valve replacement, the impact of ascending aortic dilation remains unclear. Therefore, we designed this multicenter prospective randomized controlled trial, aiming to assess the efficacy of self-expandable and balloon-expandable valves in patients with AAD with a maximum diameter of ≥45mm.

Conditions

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Aortic Stenosis Ascending Aortic Dilatation

Keywords

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Transcatheter aortic valve replacement Balloon-expandable valve Self-expandable valve Aortic stenosis Ascending aortic dilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The present study is a multi-center, open-label, two-arm randomized control trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Self-expandable valve group

Patients who undergo transcatheter aortic valve replacement using self-expandable valves

Group Type OTHER

Transcatheter aortic valve replacement

Intervention Type DEVICE

Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.

Balloon-expandable valve group

Patients who undergo transcatheter aortic valve replacement using balloon-expandable valves

Group Type OTHER

Transcatheter aortic valve replacement

Intervention Type DEVICE

Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.

Interventions

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Transcatheter aortic valve replacement

Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Severe AS defined as an aortic valve area (AVA) of 1cm2 or less or an indexed AVA of 0.6 cm2/m2 or less;
* Evaluation and selection for TAVR by the multidisciplinary heart team;
* Maximum ascending aortic diameter between 45mm and 54mm on preoperative contrast-enhanced computed tomography (CT) scan
* Anatomic suitability for a transfemoral vascular access;
* Life expectancy of more than 12 months;
* Age ≥65 years.

Exclusion Criteria

* Pure aortic regurgitation;
* History of surgical or transcatheter aortic valve replacement (valve in valve);
* History of any aortic surgery;
* Emergent surgery;
* Patients who refused to be randomized or unable to complete regular follow-up.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Beijing, Beijing Municipality, China

Site Status RECRUITING

Fuwai Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status NOT_YET_RECRUITING

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Kang An, MD

Role: CONTACT

Phone: +86-15801301740

Email: [email protected]

Facility Contacts

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Kang An, MD

Role: primary

Shiguo Li, MD

Role: primary

Wenbin Ouyang, MD

Role: primary

Other Identifiers

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2024-2486

Identifier Type: -

Identifier Source: org_study_id