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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Ascending Aortic Dilatation
• Intervention / Treatment: Device: Transcatheter aortic valve replacement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kang An, MD; Phone Number: +86-15801301740; Email: ankang913@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
      • Contact: Kang An, MD; Phone Number: +86-15801301740; Email: ankang913@126.com
  • Guangdong
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • Fuwai Shenzhen Hospital
      • Contact: Shiguo Li, MD; Phone Number: +86-15801178630; Email: drneal@163.com
  • Yunnan
    • Kunming, Yunnan, China
      • Not yet recruiting
      • Fuwai Yunnan Cardiovascular Hospital
      • Contact: Wenbin Ouyang, MD; Phone Number: +86-15601827502; Email: victorzhu909@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Self-expandable valve group; Patients who undergo transcatheter aortic valve replacement using self-expandable valves	Device: Transcatheter aortic valve replacement; Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.
Other: Balloon-expandable valve group; Patients who undergo transcatheter aortic valve replacement using balloon-expandable valves	Device: Transcatheter aortic valve replacement; Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success	(1) freedom from mortality; (2) successful access, delivery of the device, and retrieval of the delivery system; (3) correct positioning of a single prosthetic heart valve into the proper anatomical location; (4) freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; (5) intended performance of the valve (mean gradient <20mmHg, peak velocity <3m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).	Perioperative period
30-day all-cause mortality	30-day all-cause mortality	30 days
30-day adverse aortic events	Aortic-related death, aortic dissection, or aortic rupture.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year all-cause mortality	1-year all-cause mortality	1 year
1-year cardiovascular mortality	1-year cardiovascular mortality	1 year
1-year adverse aortic events	Aortic-related death, aortic dissection, or aortic rupture.	1 year
Aortic expansion rate≥3mm/year	The aortic expansion rate was defined by the change of AA diameter (before the procedure and at the latest follow-up) divided by the follow-up period.	1 year

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Aortic stenosis; Transcatheter aortic valve replacement; Self-expandable valve; Balloon-expandable valve; Ascending aortic dilation
• Additional Relevant MeSH Terms: Aortic Valve Disease; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aneurysm, Ascending Aorta; Aortic Valve Stenosis; Dilatation, Pathologic
• Other Study ID Numbers: 2024-2486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No