Comparing self-expandable and balloon-expandable heart valves for patients with aortic dilation
Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE
This study is testing whether self-expandable heart valves work better than balloon-expandable valves for patients with aortic dilation who need a heart valve replacement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06009588 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation who are undergoing transcatheter aortic valve replacement (TAVR). It focuses on patients with severe aortic stenosis and aortic dilation, evaluating the impact of valve type on procedural success and the progression of aortic dilation post-procedure. The study aims to clarify the safety and feasibility of TAVR in this specific patient population, where current guidelines recommend aortic repair if dilation exceeds 45mm.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 65 and older with severe aortic stenosis and aortic dilation measuring between 45mm and 55mm.
Not a fit: Patients with dominant aortic regurgitation, a history of aortic surgery, or those requiring emergent TAVR may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve outcomes for patients undergoing TAVR by identifying the most effective valve type for those with aortic dilation.
How similar studies have performed: While there is limited data comparing these two types of valves in this specific context, the study aims to fill a gap in knowledge regarding their performance in patients with aortic dilation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiangbin Pan, MD — Department of Structural Heart Disease, National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
- Study coordinator: Kang An, MD
- Email: ankang913@126.com
- Phone: 0085-15801301740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.