New heart valve procedure could offer safer alternative to Open-Heart surgery for seniors

NCT ID NCT07453407

Disease control Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study tests whether a newer, less invasive procedure called transcatheter aortic valve replacement (TAVR) using the J-VALVE device is as safe and effective as traditional open-heart surgery for people with severe aortic regurgitation (a leaky heart valve). About 1,250 adults aged 65 and older with severe symptoms or signs of heart strain will be enrolled. Researchers will compare death rates, strokes, and unplanned heart-related hospital stays over one year.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2038

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\) Age ≥65 years； * 2\) a. Symptomatic patients with severe AR b. Asymptomatic patients with severe AR and evidence of LV function impairment (per current ESC / ACC guidelines) Any of the following perimeters 1. LVEF ≤55% 2. LVESD \>50 mm 3. LVESDi \>22 mm/m2 4. LVESVi \>45 mL/m2 5. normal LV systolic function at rest (LVEF \>55%), and a progressive decline in LVEF on at least 3 serial studies to the low-normal range (LVEF 55% to 60%) or a progressive increase in LV dilation into the severe range (LV end-diastolic dimension \[LVEDD\] \>65 mm), * 3\) Evaluated by a multi-disciplinary heart team to be suitable for both surgery and transcatheter valve replacement * 4\) Informed of the nature of the study, agrees to its provisions, has provided written informed consent, and agrees to comply with all required post-procedure follow-up visits Exclusion Criteria: * 1\. Confirmed moderate or less AR severity (Grade≤2+) by core laboratory evaluation * 2\. Moderate or severe aortic valve stenosis * 3\. Mixed with clinical relevant severe mitral or tricuspid disease that require valve intervention * 4\. Pre-existing mechanical or bioprosthetic valve in any position. (of note, mitral ring is not an exclusion) * 5\. Subject is high-risk for SAVR as determined by the local heart team * 6\. Subject refuses SAVR as a treatment option * 7\. Subject is selected for aortic valve repair or aortic surgery * 8\. Need for emergency surgery or TAVR for any reason * 9\. Anatomical exclusion criteria (ANY of the following): 1. Aortic Annulus Perimeter \<53 mm or \>94 mm measured by CT 2. Maximal ascending aortic diameter ≥50 mm 3. Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy 4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (e.g., calcification, tortuosity). 5. Significant abdominal or thoracic aortic disease (such as porcelain aorta, severe calcification, aortic coarctation, etc.) that preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR. * 10\. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit * 11\. Cardiac resynchronization therapy (CRT) device implantation within 30 days of the screening visit * 12\. Any condition considered a contraindication to mechanical circulatory support * 13\. Hostile chest or conditions or complications from prior surgery that preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal chest wall, adhesion of aorta or IMA to sternum, etc.) * 14\. Subject refuses blood transfusion * 15\. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention * 16\. Evidence of acute myocardial infarction within 30 days of the screening visit * 17\. Any percutaneous coronary or peripheral interventional procedure performed within 30 days of the screening visit (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe) * 18\. Complex coronary artery disease (one of the following): 1. Unprotected left main coronary artery disease ≥50% 2. True bifurcation lesion (Medina: 1.1.1) and the diameter of the branch vessels is \>2.5 mm 3. Chronic total occlusion (CTO) 4. Long lesion, expected stent length \>38 mm 5. Multivessel lesion (at least 2 coronary arteries require interventional treatment) 6. Need to use multiple stents (planned \> 3 stents) 7. Lesion with in-stent restenosis 8. Severe calcification lesion 9. Coronary ostial lesion 10. Heart Team assessment that optimal revascularization cannot be performed with either CABG at the time of SAVR or PCI at the time of TAVR. * 19\. Symptomatic carotid or vertebral artery disease or carotid intervention within 30 days of the screening visit * 20\. Stroke or transient ischemic attack (TIA) within 90 days of the screening visit * 21\. Severe left ventricular dysfunction, defined as a resting left ventricular ejection fraction \<25%; or left ventricular end-systolic diameter (LVESD) \>70 mm; or the presence of an artificial heart or left ventricular assist device; or being listed for heart transplantation or status post heart transplantation. * 22\. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory * 23\. Cardiac imaging (echocardiography, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation * 24\. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure * 25\. Uncontrolled atrial fibrillation (i.e., resting heart rate \>120 bpm) * 26\. Hemodynamically significant hypertrophic Obstructive cardiomyopathy (HOCM), Peak LVOT gradient ≥50mmHg (resting or provoked) ESC 2022/ ACC 2020 * 27\. Untread Leukopenia (WBC\<3.0\*109/L), Untread Thrombocytopenia (Platelet count \<50\*109), history of bleeding diathesis or coagulopathy, or hypercoagulable states, Acute posthemorrhagic anemia (hemoglobin \<9.0 g/dL) * 28\. Severe chronic obstructive pulmonary disease (COPD) (FEV1 \<50% predicted) or currently on home oxygen * 29\. Severe pulmonary hypertension (e.g., PA systolic pressure ≥2/3 systemic pressure) * 30\. Severe chronic liver disease (Child-Pugh C) or any active liver disease * 31\. Renal insufficiency (eGFR\<30mL/min/1.73m²) and/or requiring chronic peritoneal dialysis at the time of screening and/or requiring chronic hemodialysis at the time of screening * 32\. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks * 33\. Subject has a known hypersensitivity or contraindication to all anticoagulation/antiplatelet medications (or inability to be anticoagulated for the index procedure), implant-related materials, or sensitivity to contrast media which cannot be adequately pre-medicated * 34\. Inability to tolerate anti-thrombotic/anticoagulation therapy during or after the valve implant procedure * 35\. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy * 36\. BMI \>50 kg/m2 or \<18.5 kg/m2 * 37\. Estimated life expectancy \<24 months due to associated non- cardiac comorbid conditions * 38\. Immobility that would prevent completion of study procedures * 39\. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary * 40\. Severe cognitive decline (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits) * 41\. Pregnancy or intent to become pregnant (women suspected of becoming pregnant must have a negative serum or urine test for human chorionic gonadotropin before being included in the study) * 42\. Other patients considered unsuitable for this clinical study by the investigator

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic insufficiency Aortic regurgitation Aortic valve insufficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

28 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Beijing Anzhen Hospital Affiliated to Capital Medical University
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100000, China
Cheng Hsin General Hospital
NOT_YET_RECRUITING

Taibei, Taiwan, 100-116, China
Fujian Medical University Union Hospital
NOT_YET_RECRUITING

Fuzhou, Fujian, 350000, China
Fuwai Central China Cardiovascular Hospital
NOT_YET_RECRUITING

Zhengzhou, Henan, 450000, China
Fuwai Hospital, Chinese Academy of Medical Sciences
NOT_YET_RECRUITING

Beijing, Beijing Municipality, 100000, China
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING

Guangzhou, Guangdong, 510000, China
Kunming Yan'an Hospital
NOT_YET_RECRUITING

Kunming, Yunnan, 650000, China
Nanjing First Hospital
NOT_YET_RECRUITING

Nanjing, Jiangsu, 210000, China
National Taiwan University Hospital
NOT_YET_RECRUITING

Taibei, Taiwan, 100116, China
Prince of Wales Hospital
NOT_YET_RECRUITING

Hong Kong, Hong Kong, 999077, China
Qilu Hospital, Shandong University
NOT_YET_RECRUITING

Jinan, Shandong, 250000, China
Queen Mary Hospital
NOT_YET_RECRUITING

Hong Kong, Hong Kong, 999077, China
Shanghai Chest Hospital
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200000, China
Shanghai East Hospital
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200000, China
Shanghai Geriatric Medical Center
NOT_YET_RECRUITING

Shanghai, Shanghai Municipality, 200000, China
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING

Qingdao, Shandong, 266000, China
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING

Hefei, Anhui, 230000, China
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING

Hangzhou, Zhejiang, 310000, China
The Second Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING

Nanchang, Jiangxi, 330000, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING

Hangzhou, Zhejiang, 310009, China
The Second Xiangya Hospital, Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410000, China
Tianjin Chest Hospital
NOT_YET_RECRUITING

Tianjin, Tianjin Municipality, 300000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING

Wuhan, Hubei, 430000, China
West China Hospital, Sichuan University
NOT_YET_RECRUITING

Chengdu, Sichuan, 610000, China
Xiangya Hospital, Central South University
NOT_YET_RECRUITING

Changsha, Hunan, 410000, China
Xijing Hospital affiliated to Air Force Medical University
NOT_YET_RECRUITING

Xi'an, Shaanxi, 710000, China
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING

Wuhan, Hubei, 430000, China
Zhongshan Hospital, Fudan University
RECRUITING

Shanghai, Shanghai Municipality, 200000, China

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