An observational study in Aortic Stenosis and AORTIC VALVE DISEASES, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Not yet recruiting at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Observational
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 14th largest by planned enrollment of the 20 observational ones that give a count, is one of 6 that started in 2026, is one of 20 observational ones, reaches primary completion later than 41 of the 48 other live ones, and was the 63rd registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
Browse Aortic Valve Stenosis studies →41 of the 67 studies in Aortic Valve Stenosis with a site in China are open now. Recruiting first, the newest first:
West China Hospital · Sites in China
Yan'an Affiliated Hospital of Kunming Medical University · Sites in China
Beijing Balance Medical Technology Co., Ltd · Sites in China
Anhui Provincial Cancer Hospital · Sites in China
RenJi Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
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: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
67 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 6 started in 2026.
This study's planned enrollment of 170 is below the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
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.
This tab as a report to print or save as PDF → With an account.
27 of 67 have an industry lead sponsor. The 10 most frequent:
Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 147 studies on the registry; 51 are open to participants now.
Chinese Academy of Medical Sciences, Fuwai Hospital has 4 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 tab as a report to print or save as PDF → With an account.
In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.
severe symptomatic aortic valve stenosis (AS) patients with type-0 bicuspid anatomy
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.
Severe AS, defined as follows:
a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a \<50%.
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 share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with severe, calcific aortic stenosis and with Type-0 bicuspid anatomy confirmed by MDCT.
Device: Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement for patients with Type-0 bicuspid aortic stenosis.
Also known as: TAVR
The composite of all-cause mortality, stroke, or rehospitalization
The composite of all-cause mortality, stroke, or rehospitalization
Time frame: At 1 year after procedure
The composite of all-cause mortality, stroke, or rehospitalization
The composite of all-cause mortality, stroke, or rehospitalization
Time frame: At 30 days after procedure
The composite of device success
The composite of device success at 30 days comprising the following: 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, intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, and less than moderate aortic regurgitation), according to the VARC-3 definition
Time frame: At 30 days after procedure
Annular rupture
Annular rupture
Time frame: At discharge(assessed up to 30 days)
Paravalvular leakage
Paravalvular leakage
Time frame: At discharge (assessed up to 30 days) , 30 days, 1year
Technical success
Technical success (at exit from procedure room): * 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
Time frame: At exit from procedure room
Procedural success
Procedural success at 30 days defined as meeting all of the following: * Device success * No device or procedure related SAE's as follows: 1. Life-threatening bleed (BARC 3b or greater) 2. Major vascular or cardiac structural complications requiring unplanned reintervention or surgery 3. Stage 2 or 3 AKI (includes new dialysis) 4. MI or need for PCI/CABG 5. Severe heart failure or hypotension requiring IV inotrope \>12 hours, ultrafiltration or mechanical circulatory support 6. Prolonged intubation \> 48 hours 7. Need for a permanent pacemaker implant or continuous atrial fibrillation
Time frame: At 30 days
Mortality (all cause & cardiovascular)
Mortality (all cause \& cardiovascular)
Time frame: At 30 days,1year
Stroke (disabling and nondisabling)
Stroke (disabling and nondisabling)
Time frame: At 30 days, 1year
Rehospitalization (procedure, valve and heart failure related)
Rehospitalization (procedure, valve and heart failure related)
Time frame: At 30 days, 1year
Major vascular complication
Major vascular complication
Time frame: At 30 days, 1year
Major or life-threatening bleeding
Major or life-threatening bleeding
Time frame: At 30 days, 1year
Myocardial infarction
Myocardial infarction
Time frame: At 30 days, 1year
Acute kidney injury stage 2 or 3
Acute kidney injury stage 2 or 3
Time frame: At 30 days, 1year
Need for a permanent pacemaker
Need for a permanent pacemaker
Time frame: At 30 days, 1year
New onset atrial fibrillation
New onset atrial fibrillation
Time frame: At 30 days, 1year
Valve endocarditis
Valve endocarditis
Time frame: At 30 days, 1year
Valve thrombosis
Valve thrombosis
Time frame: At 30 days, 1year
New York Heart Association class
New York Heart Association class
Time frame: At 30 days, 1year
Patient-prosthesis mismatch
Patient-prosthesis mismatch
Time frame: At 30 days, 1year
Index hospitalization days
Index hospitalization days
Time frame: At discharge (assessed up to 30 days)
Health status as evaluated by Quality of Life questionnaires - KCCQ
Health status as evaluated by Quality of Life questionnaires - KCCQ
Time frame: At baseline, 30 days, 1year
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Aug 2028, 28 months later.
Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 28 months is below that.
Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences, Fuwai Hospital →