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

Not Applicable

Recruiting

• Conditions: Ascending Aortic Dilatation; Aortic Stenosis
• Interventions: Device: self-expandable valves; Device: balloon-expandable valves

• Registration Number: NCT06009588
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-08-12
• Study First Submitted QC: 2023-08-20
• Study First Posted: 2023-08-24
• Study Start: 2023-08-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-expandable valve group	self-expandable valves	Patients using self-expandable valves
Balloon-expandable valve group	balloon-expandable valves	Patients using balloon-expandable valves

Primary Outcome Measures

Name	Time	Method
The rate of device success	30 days	Device success is defined as following: 1. Technical success (Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication); 2. Freedom from mortality; 3. Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication; 4. Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index $0.25, and less than moderate aortic regurgitation)
30-day all-cause mortality	30 days after TAVR procedure	all-cause mortality within 30 days after TAVR procedure
30-day adverse aortic events	30 days after TAVR procedure	aortic death, aortic dissection, or aortic rupture

Secondary Outcome Measures

Name	Time	Method
1-year cardiovascular mortality	1 year after TAVR procedure	Related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis), or other clear cardiovascular cause
1-year adverse aortic events	1 year after TAVR procedure	aortic death, aortic dissection, or aortic rupture
Hospitalization (or re-hospitalization)	1 year after TAVR procedure	Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.; Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition. Visits to urgent care centres or emergency departments \<24 h may also be included if substantive intensification of therapy changes (e.g. heart failure episodes) are enacted (e.g. intravenous diuretics, significant increases in drug therapy dosages or addition of new pharmacotherapy agents)
1-year all-cause mortality	1 year after TAVR procedure	all-cause mortality
Ascending aortic diameter expansion rate ≥3mm/year	1 year after TAVR procedure	Expansion rate was calculated as the change of ascending aortic diameters (before the procedure and at the latest follow-up) divided by the follow-up period.

Trial Locations

Locations (1)

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