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

NCT06743568 | Recruiting DMC

• 1 other identifier: 2024-2486
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Aortic Stenosis; Ascending Aortic Dilatation

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 1-year all-cause mortality

  1 year

• 1-year cardiovascular mortality

  1 year

• 1-year adverse aortic events

  1 year

• Aortic expansion rate≥3mm/year

  1 year

Study Arms (2)

Self-expandable valve group

OTHER

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

Device: Transcatheter aortic valve replacement

Balloon-expandable valve group

OTHER

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

Device: Transcatheter aortic valve replacement

Interventions

Transcatheter aortic valve replacement DEVICE

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

Balloon-expandable valve group; Self-expandable valve group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (3)

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

Beijing, Beijing Municipality, China

RECRUITING

Fuwai Shenzhen Hospital

Shenzhen, Guangdong, China

NOT YET RECRUITING

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Aneurysm, Ascending Aorta

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Kang An, MD

CONTACT

+86-15801301740; ankang913@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The present study is a multi-center, open-label, two-arm randomized control trial.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)