HANGZHOU Solution in Bicuspid AS Undergoing TAVR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Mean gradient ≥40 mmHg
Maximal aortic valve velocity ≥4.0 m/sec
Disqualifiers
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)].
Trial design
Design model
Parallel
Treatments tested in this trial
TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)
DeviceTranscatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)
TAVR with Venus A plus using annular sizing and THV implantation technique
DeviceTranscatheter aortic valve replacement (TAVR) with Venus A plus using annular sizing and THV implantation technique (Traditional sizing strategy)
Treatment groups
508 Participants
are divided into 2 treatment groupsGroup A: TAVR with Supra-annular sizing strategyExperimental treatment 1 intervention
Group B: TAVR with Annulus based sizing strategyOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Composite of all-cause mortality, disabling stroke, new permanent pacemaker implantation and moderate or severe prosthetic valve regurgitation at 1 month (per Valve Academic Research Consortium-2 \[VARC-2\] criteria)
Time frame
1 monthSecondary outcomes
1
Deaths (all-cause mortality) at 1 month
Number of deaths from any cause mortality at 1 month
Time frame
1 month2
Deaths (all-cause mortality) at 1 year
Time frame
1 year3
Deaths (all-cause mortality) at 2 years
Time frame
2 years4
Deaths (all-cause mortality) at 3 years
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Venus MedTech (HangZhou) Inc.
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
Chinese PLA General Hospital
Collaborator
Fujian Medical University Union Hospital
Collaborator
Xiamen University Affiliated Cardiovascular Hospital
Collaborator
The Second People's Hospital of GuangDong Province
Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Henan Provincial Chest Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Central South University
Collaborator
Northern Jiangsu People's Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Shanxi Cardiovascular Hospital
Collaborator
Tianjin Chest Hospital
Collaborator
Ning Bo First Hospital
Collaborator
Source ClinicalTrials.gov