Brief Title
HANGZHOU Solution in Bicuspid AS Undergoing TAVR
Official Title
HANGZHOU Solution for Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement by Using Supra-annular Structure Based Balloon Sizing Strategy
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 undergoing transcatheter aortic valve replacement (TAVR) with self-expanding
valves (SEVs): a randomized superiority trial
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 had similar 30-day mortality as well as stroke and new pacemaker
implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL,
conversion to surgery and device failure. Event rates significantly decreased with the use of
new-generation devices, but TAVR still showed better procedural results in TAV compared to
BAV.
Clinical experience in China suggests bicuspid aortic valves and heavy calcium burden are
more common among TAVR candidates. Morphological characteristics at supra-annular structure
(from annulus to the level of sinotubular junction) are quite complex in bicuspid AS,
especially concomitant with heavily calcified leaflets. Because only two leaflet hinge points
provide the definition of the annulus plane, current CT-based annulus measurements might not
be accurate under these circumstances. From previous single center clinical practice, "waist
sign" above the annulus during balloon aortic valvuloplasty in TAVR was often observed in
patients with bicuspid AS, indicating that the supra-annular structure may serve a key role
in anchoring the THV.
Therefore, we developed a balloon based supra-annular sizing strategy (Hangzhou Solution) for
SEV implantation in bicuspid AS. From our single center experience, the device success rate
and pacemaker implantation rate were relatively low.
The aim of this study is 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).
Study Type
Interventional
Primary Outcome
Composite of all-cause mortality rate, disabling stroke rate, new permanent pacemaker implantation rate and moderate or severe prosthetic valve regurgitation rate at 1 month
Secondary Outcome
Deaths (all-cause mortality) at 1 month
Condition
Aortic Stenosis
Intervention
TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)
Study Arms / Comparison Groups
TAVR with Supra-annular sizing strategy
Description: Experimental: Supra-annular sizing strategy (Hangzhou Solution). Pre-dilation with balloon size (20/23/26mm Z-MED) just below the annular size. Waist sign with less than mild contrast regurgitation: Venus A plus Valve down size and Target implant depth 0-2mm. No waist sign and/or contrast regurgitation or unable to finish supra-annular sizing: annular sizing Venus A plus Valve with implant depth 4-6mm.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
508
Start Date
February 1, 2021
Completion Date
March 1, 2028
Primary Completion Date
March 1, 2024
Eligibility Criteria
Inclusion 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 respective clinical site.
Exclusion Criteria:
- 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.
Gender
All
Ages
60 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jian'an Wang, PhD, MD, +86057187783777, [email protected]
Administrative Informations
NCT ID
NCT04722796
Organization ID
2021-0007
Responsible Party
Sponsor
Study Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Venus MedTech (HangZhou) Inc.
Study Sponsor
Jian'an Wang, PhD, MD, Study Chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Verification Date
January 2021