HANGZHOU Solution in Bicuspid AS Undergoing TAVR

NCT04722796 | Recruiting DMC

• 1 other identifier: 2021-0007
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 18

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

Conditions

Aortic Stenosis; Aortic Stenosis With Bicuspid Valve

Keywords

Transcatheter aortic valve replacement; Aortic Stenosis with Bicuspid Valve; supra-annular sizing

Outcome Measures

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)

  1 month

Secondary Outcomes (82)

• Deaths (all-cause mortality) at 1 month

  1 month

• Deaths (all-cause mortality) at 1 year

  1 year

• Deaths (all-cause mortality) at 2 years

  2 years

• Deaths (all-cause mortality) at 3 years

  3 years

• Deaths (all-cause mortality) at 4 years

  4 years

Study Arms (2)

TAVR with Supra-annular sizing strategy

EXPERIMENTAL

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.

Device: TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)

TAVR with Annulus based sizing strategy

OTHER

Control: Traditional sizing strategy (Annulus based sizing strategy). Pre-dilation with balloon size (20/23/26mm Z-MED) just below the annular size. Annular sizing Venus A plus Valve with implant depth 4-6mm.

Device: TAVR with Venus A plus using annular sizing and THV implantation technique

Interventions

TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution) DEVICE

Transcatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)

Also known as: Hangzhou solution

TAVR with Supra-annular sizing strategy

TAVR with Venus A plus using annular sizing and THV implantation technique DEVICE

Transcatheter aortic valve replacement (TAVR) with Venus A plus using annular sizing and THV implantation technique (Traditional sizing strategy)

Also known as: Traditional sizing strategy (Annulus based sizing strategy)

TAVR with Annulus based sizing strategy

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 \[(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)\].
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• 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

Study Sites (18)

The First affiliated hospital of bengbu medical college

Bengbu, Anhui, China

NOT YET RECRUITING

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

NOT YET RECRUITING

Xiamen University Affiliated Cardiovascular Hospital

Xiamen, Fujian, China

NOT YET RECRUITING

Guangdong People's Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Zhengzhou Cardiovascular Hospital

Zhengzhou, Henan, 450016, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

NOT YET RECRUITING

Hennan Provincial Chest Hospital

Zhengzhou, Hennan, China

NOT YET RECRUITING

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

The Second XIANGYA Hospital Of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

NOT YET RECRUITING

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, 030024, China

NOT YET RECRUITING

tianjin Chest Hospital

Tianjing, Tianjing, 300222, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine.

Hangzhou, Zhejiang, 310006, China

RECRUITING

Ning Bo First Hospital

Ningbo, Zhejiang, 315010, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Jian'an Wang, PhD, MD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

Central Study Contacts

Jian'an Wang, PhD, MD

CONTACT

+86057187783777; wja@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and ourcome assessor are blind to treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: April 12, 2021
• Primary Completion: April 1, 2024
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (18)