Status:
RECRUITING
HANGZHOU Solution in Bicuspid AS Undergoing TAVR
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Venus MedTech (HangZhou) Inc.
The First Affiliated Hospital of Bengbu Medical University
Conditions:
Aortic Stenosis
Aortic Stenosis With Bicuspid Valve
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
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 underg...
Detailed Description
Transcatheter aortic valve replacement (TAVR) has emerged as a favorable alternative for severe symptomatic aortic stenosis (AS) patients from low to high surgical risk. BAV patients treated with TAVR...
Eligibility Criteria
Inclusion
- 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 respective clinical site.
Exclusion
- 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 \[(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].
- 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 the procedure or compliance with follow-up visits).
- 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 irregularities) of the abdominal or thoracic aorta, severe"unfolding" and horizontal aorta(Annular Angulation\>70°).
- 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.
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT04722796
Start Date
April 12 2021
End Date
April 1 2028
Last Update
June 2 2021
Active Locations (18)
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1
The First affiliated hospital of bengbu medical college
Bengbu, Anhui, China
2
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
3
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
4
Xiamen University Affiliated Cardiovascular Hospital
Xiamen, Fujian, China