Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI

NCT02221921 | Unknown DMC

• 2 other identifiers: U0000SYVMicroPort Medical
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Calcification

Outcome Measures

Primary Outcomes (1)

• All cause mortality or major stroke at 12 months.

  12 months

Secondary Outcomes (4)

• MACCE(major adverse cardiovascular and cerebrovascular events)

  30 days, 3, 6 and 12 months

• Device success

  7 days post-operation

• Valve performance

  30 days, 3, 6 and 12 months

• The improvement of heart function

  30 days, 3, 6 and 12 months

Study Arms (1)

MicroPort's Transcatheter Aortic Valve and Delivery System

EXPERIMENTAL

single arm with intervention that percutaneous implantation of the MicroPort's Transcatheter Aortic Valve and Delivery System

Device: MicroPort's Transcatheter Aortic Valve and Delivery System

Interventions

MicroPort's Transcatheter Aortic Valve and Delivery System DEVICE

MicroPort's Transcatheter Aortic Valve and Delivery System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older, male or non pregnant women;
• Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥ 40 mmHg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of \< 1.0 cm2 (or AVA index \< 0.6 cm2/m2)
• Symptomatic due to aortic valve stenosis as demonstrated by NYHA (New York Heart Association) Functional Class ≥ II
• Expectation of life\>12 months
• Calcific aortic stenosis, which is suitable for transcatheter aortic valve implantation anatomically
• is evaluated by at least two cardiovascular physicians, and they agreed that medical factors precluding operation suitable for surgery (the probability of death or serious, irreversible morbidity exceeded 50%)
• The subject agreed to comply follow-up evaluation

You may not qualify if:

• Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
• aortic valve is a congenital unicuspid valve, or is non-calcified.
• Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days
• Implanted any heart valve prosthesis, prosthetic valve ring, severe（\>3＋）mitral valve insufficiency
• Blood dyscrasia such as leukopenia (WBC \< 3×109/L), acute anemia (Hgb \< 90 g/L), thrombocytopenia (PLT \< 50×109/L), bleeding diathesis, or history of coagulopathy.
• Untreated clinically significant coronary artery disease requiring revascularization
• Hemodynamic instability requiring mechanical cardiac assist or mechanical hemodynamic support devices
• Need for emergency surgery for any reason
• Hypertrophic cardiomyopathy with or without obstruction
• Severe ventricular dysfunction with LVEF (Left ventricular ejection fraction) \< 20%
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months
• A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
• Native aortic annulus size \< 17 mm or\> 29 mm.
• Patient refuses aortic valve replacement surgery.

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve, Calcification of

Condition Hierarchy (Ancestors)

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

Study Officials

• JunBo Ge, Medical Doctor, Professor

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Liu, Medical Doctor

CONTACT

+86 13911002920; davidliu@coremed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 21, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2021
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

CN (1)