Aortic Stenosis, Ascending Aortic Dilatation
Conditions
Keywords
Transcatheter aortic valve replacement, Balloon-expandable valve, Self-expandable valve, Aortic stenosis, Ascending aortic dilation
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.
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.
Interventions
DEVICETranscatheter aortic valve replacement
Eligible patients will be randomized 1:1 to self-expandable valve group or balloon-expandable valve group.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The present study is a multi-center, open-label, two-arm randomized control trial.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device success | Perioperative period | (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). |
| 30-day all-cause mortality | 30 days | 30-day all-cause mortality |
| 30-day adverse aortic events | 30 days | Aortic-related death, aortic dissection, or aortic rupture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year all-cause mortality | 1 year | 1-year all-cause mortality |
| Aortic expansion rate≥3mm/year | 1 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 cardiovascular mortality | 1 year | 1-year cardiovascular mortality |
| 1-year adverse aortic events | 1 year | Aortic-related death, aortic dissection, or aortic rupture. |
Countries
China
Contacts
Primary ContactKang An, MD
Outcome results
None listed