An interventional study of Transcatheter aortic valve replacement in Aortic Stenosis and Ascending Aortic Dilatation, sponsored by China National Center for Cardiovascular Diseases. Recruiting at 3 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Treatment
Among 67 studies in Aortic Valve Stenosis with a site in China — 41 open to participants now, 49 under way, 3 of them phase 3. Aortic Valve Stenosis · China.
Among the 67 studies in Aortic Valve Stenosis with a site in China, this one is the 27th largest by planned enrollment of the 47 interventional ones, is one of 10 that started in 2024, is one of 37 with no phase, reaches primary completion later than 24 of the 48 other live ones, and was the 47th registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 100 is below the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →41 of the 67 studies in Aortic Valve Stenosis with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →67 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 10 started in 2024.
Median enrollment 120 across the 47 interventional studies, 465 across the 20 observational. Of the 7 that completed or were terminated, 2 (29%) have results posted.
27 of 67 have an industry lead sponsor. The 10 most frequent:
China National Center for Cardiovascular Diseases is the lead sponsor of 269 studies on the registry; 141 are open to participants now.
China National Center for Cardiovascular Diseases has 6 studies filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
5 of the studies in Aortic Valve Stenosis with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07335900RenJi HospitalA Clinical Study Using FAPI-PET Imaging to Assess the Postoperative Effects of TAVI in Patients With Aortic Stenosis | 2026-12-30 |
| NCT07390513Chinese Academy of Medical Sciences, Fuwai HospitalElectrophysiological Outcomes After Transcatheter Aortic Valve Replacement | 2026-12-31 |
| NCT06891079Xijing HospitalVideodensitometric Angiographic Assessment of AR in the Cath-lab for Intraprocedural Guidance of TAVI in CHINA | 2026-12-31 |
| NCT07035847Chinese Academy of Medical Sciences, Fuwai HospitalTransaxillary TAVR With Solely Echocardiography Guidance | 2026-12-31 |
| NCT07414342Beijing Balance Medical Technology Co., LtdSafety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis | 2027-09 |
Among the 67 studies in Aortic Valve Stenosis with a site in China, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who undergo transcatheter aortic valve replacement using self-expandable valves
Device: Transcatheter aortic valve replacement
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.
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).
Time frame: Perioperative period
30-day all-cause mortality
30-day all-cause mortality
Time frame: 30 days
30-day adverse aortic events
Aortic-related death, aortic dissection, or aortic rupture.
Time frame: 30 days
1-year all-cause mortality
1-year all-cause mortality
Time frame: 1 year
1-year cardiovascular mortality
1-year cardiovascular mortality
Time frame: 1 year
1-year adverse aortic events
Aortic-related death, aortic dissection, or aortic rupture.
Time frame: 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.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Jul 2026, 21 months after the start.
Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 21 months is below that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
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China National Center for Cardiovascular Diseases →