Aortic Valve DiseaseSEASON-ARNCT04864145
Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation
A study testing Transcatheter Aortic Valve Implantation and Medical therapy in people with Aortic Valve Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Prospective, multicenter, randomized trial. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Transcatheter Aortic Valve Implantation and Medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2021to 30 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) > 65mm or left ventricular end-systolic dimension (LVESD) > 50mm;
- Severe aortic valve regurgitation, and mean pressure gradient < 20mmHg; Annular perimeter ≤ 85 mm;
- The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;
- STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement:
- Severe aorta calcification or active ascending aorta atherosclerotic plaque
- History of mediastinum radiotherapy
Show all 11Show fewer
- Past mediastinitis
- Presence of unobstructed coronary bypass implants
- Previous more than two cardiothoracic surgeries
- Liver cirrhosis
- Other surgical risk factors
Who cannot join
- Age < 60 years old;
- Ascending aorta diameter >45mm;
- Coronary multi-vessel disease (SYNTAX score >32);
- Life expectancy <1 year;
- Left ventricular ejection fraction <30%;
- Acute myocardial infarction within 30 days;
- Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents);
- Other situations judged by the researcher as unsuitable for participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Shaoliang Chen, MD, +86 13605157029, chmengx@126.com
About this study
Official title: Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation: a Prospective, Multicenter, Randomized Study
Prospective, multicenter, randomized trial.
Read the detailed description
Patients with severe native aortic valve regurgitation (AR) who have symptoms, impaired LVEF (≤55%) or left ventricular enlargement have the indications for surgery. According to data from the Euro Heart Survey, only 21.8% with LVEF 30-50% and 2.7% with LVEF <30% were referred for surgical aortic valve replacement (SAVR) among patients with severe native aortic regurgitation. Advanced age and comorbidities were often considered as main reasons to refuse SAVR. The annual mortality of untreated patients with severe AR is 10-20%. Pure native AR is always an exclusion criterion in all randomized controlled trials on transcatheter aortic valve implantation (TAVR) because the specific anatomical features can preclude adequate valve implantation. Several small, retrospective studies showed that off-label use of TAVR appears to be a feasible treatment choice for AR patients at high risk for SAVR. The present study aims to investigate the use of TAVR in AR patients.
- Conditions
- Aortic Valve Disease
- Being tested
- Transcatheter Aortic Valve Implantation, Medical therapy
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ImplantationDevice
Also called The VitaFlow™ system (MicroPort®, Shanghai, China)
The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.
Medical therapyDrug
Also called Optimal medical therapy
Angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers.
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy | Active comparator | Patients in medical therapy will receive conservative care, mainly including angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers. Receives: Drug: Medical therapy |
| Transcatheter Aortic Valve Implantation | Experimental | Patients in TAVR group will receive transcatheter aortic valve replacement. Receives: Device: Transcatheter Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical worsening
A composite of all cause death, disabling stroke, or heart failure rehospitalization
Measured: 12 months
Secondary outcomes (8)
Procedural complications
Any aortic dissection, annular rupture, coronary artery occlusion, vascular complications, permanent pacemaker implantation.
Measured: 12 months
6-minute walk distance
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
Measured: 12 months
New York Heart Association (NYHA) functional class
Classification of function capacity of the NYHA.
Measured: 12 months
Stroke
Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
Measured: 12 months
Mortality
All-cause, cardiovascular, and non-cardiovascular mortality
Measured: 12 months
Bleeding Complications
The original VARC definitions with BARC classifications
Measured: 12 months
Prothetic valve dysfunction
Any prothetic aortic valve stenosis, prothesis-patient mismatch, prosthetic aortic valve regurgitation
Measured: 12 months
Rehospitalization
Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start21 May 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoliang Chen, MD, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Shao-Liang Chen, MD, PhD, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864145
- Sponsor's protocol ID
- NFH20210325
- Acronym
- SEASON-AR
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao XF, Wang Y, Jiang H, Li B, Shao YB, Luo J, Ren FX, Ouyang F, Chen ZK, Yuan HT, Wang C, Han B, Xiao PX, Yuan YQ, Yang ZW, Miao L, Ma X, Yang J, You DF, Chen SL, Zhang JJ; SEASON-AR Trial Investigators. Transcatheter Aortic Valve Replacement in Pure Aortic Regurgitation: The Randomized SEASON-AR Clinical Trial. Circulation. 2026 Oct 31. doi: 10.1161/CIRCULATIONAHA.126.082827. Online ahead of print.
PubMed 42965504
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation: a Prospective, Multicenter, Randomized Study
- ClinicalTrials.gov ID
- NCT04864145
- Acronym / sponsor ID
- SEASON-AR / NFH20210325
- Conditions
- Aortic Valve Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2031 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, randomized trial.
Detailed description
Patients with severe native aortic valve regurgitation (AR) who have symptoms, impaired LVEF (≤55%) or left ventricular enlargement have the indications for surgery. According to data from the Euro Heart Survey, only 21.8% with LVEF 30-50% and 2.7% with LVEF <30% were referred for surgical aortic valve replacement (SAVR) among patients with severe native aortic regurgitation. Advanced age and comorbidities were often considered as main reasons to refuse SAVR. The annual mortality of untreated patients with severe AR is 10-20%. Pure native AR is always an exclusion criterion in all randomized controlled trials on transcatheter aortic valve implantation (TAVR) because the specific anatomical features can preclude adequate valve implantation. Several small, retrospective studies showed that off-label use of TAVR appears to be a feasible treatment choice for AR patients at high risk for SAVR. The present study aims to investigate the use of TAVR in AR patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical therapy | Active comparator | Drug: Medical therapyPatients in medical therapy will receive conservative care, mainly including angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers. |
| Transcatheter Aortic Valve Implantation | Experimental | Device: Transcatheter Aortic Valve ImplantationPatients in TAVR group will receive transcatheter aortic valve replacement. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) > 65mm or left ventricular end-systolic dimension (LVESD) > 50mm;
- Severe aortic valve regurgitation, and mean pressure gradient < 20mmHg; Annular perimeter ≤ 85 mm;
- The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;
- STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement:
Key exclusion criteria (8 listed)
- Age < 60 years old;
- Ascending aorta diameter >45mm;
- Coronary multi-vessel disease (SYNTAX score >32);
- Life expectancy <1 year;
- Left ventricular ejection fraction <30%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve ImplantationAlso: The VitaFlow™ system (MicroPort®, Shanghai, China)The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve. | Device | Transcatheter Aortic Valve Implantation |
| Medical therapyAlso: Optimal medical therapyAngiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers. | Drug | Medical therapy |
Primary outcome
Clinical worsening
Time frame: 12 months
A composite of all cause death, disabling stroke, or heart failure rehospitalization
8 secondary outcomes
Procedural complications
Time frame: 12 months
6-minute walk distance
Time frame: 12 months
New York Heart Association (NYHA) functional class
Time frame: 12 months
Stroke
Time frame: 12 months
Mortality
Time frame: 12 months
Bleeding Complications
Time frame: 12 months
Prothetic valve dysfunction
Time frame: 12 months
Rehospitalization
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 42965504Gao XF, Wang Y, Jiang H, Li B, Shao YB, Luo J, Ren FX, Ouyang F, Chen ZK, Yuan HT, Wang C, Han B, Xiao PX, Yuan YQ, Yang ZW, Miao L, Ma X, Yang J, You DF, Chen SL, Zhang JJ; SEASON-AR Trial Investigators. Transcatheter Aortic Valve Replacement in Pure Aortic Regurgitation: The Randomized SEASON-AR Clinical Trial. Circulation. 2026 Oct 31. doi: 10.1161/CIRCULATIONAHA.126.082827. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shao-Liang Chen, MD, PhD study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Implantation and Medical therapy in people with Aortic Valve Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun-Jie Zhang, MD, PhD (+86-25-52271350, jameszll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical worsening (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04864145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.