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New treatment option for Aortic Stenosis
Official title HANGZHOU Solution in Bicuspid AS Undergoing TAVR
ClinicalTrials.gov ID: NCT04722796
What this study is testing
- What it's testing
- To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- Age ≥ 65 years
- Age \<65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System...
- Severe, bicuspid aortic stenosis:
- Mean gradient ≥40 mmHg
- Maximal aortic valve velocity ≥4.0 m/sec
You likely can't join if
- Any contra-indication for Self-expanding bioprosthetic aortic valve deployment
- Leukopenia (WBC \< 3000 cell/mL), acute anemia (Hgb \< 9 g/dL), Thrombocytopenia (Plt\< 50,000 cell/mL).
- Active sepsis, including active bacterial endocarditis with or without treatment;
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK...
- Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
- Estimated life expectancy \< 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary...
See the full eligibility criteria
- Age ≥ 65 years
- Age \<65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment;
- Severe, bicuspid aortic stenosis:
- Mean gradient ≥40 mmHg
- Maximal aortic valve velocity ≥4.0 m/sec
- Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2)
- NYHA classification ≥ II;
- Type 0, type 1 (Sievers classification) by MDCT
- Perimeter-derived annulus diameter ranges from 20.0 mm to 29.0 mm;
- Transfemoral TAVR
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the...
- Any contra-indication for Self-expanding bioprosthetic aortic valve deployment
- Leukopenia (WBC \< 3000 cell/mL), acute anemia (Hgb \< 9 g/dL), Thrombocytopenia (Plt\< 50,000 cell/mL).
- Active sepsis, including active bacterial endocarditis with or without treatment;
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation...
- Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.
- Estimated life expectancy \< 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.
- Any Emergent surgery required before TAVR procedure.
- A known hypersensitivity or contraindication to any of the following that cannot be adequately medicated:aspirin or heparin (HIT/HITTS) and bivalirudin, clopidogrel,Nitinol (titanium or nickel),contrast media
- Gastrointestinal (GI) bleeding that would preclude anticoagulation.
- Subject refuses a blood transfusion.
- Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from...
- Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams.
- Currently participating in an investigational drug or another device study (excluding registries).
- Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM).
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Severe mitral stenosis amenable to surgical replacement or repair.
- Aortic valve type cannot be determined (Sievers classification).
- Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (\> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface...
- Ascending aorta diameter \> 50 mm.
- Aortic or iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Patient is considered high risk for TAVR by CT corelab, including coronary obstruction, annular rupture and other severe TAVR-Related complications.
- Previous pacemaker implantation.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Zhengzhou, Hennan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Yangzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Qingdao, Shandong, China
- Taiyuan, Shanxi, China
- Tianjing, Tianjing, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.