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

Aortic Valve Stenosis Clinical Trial

Official title:

Clinical Evaluation of the Safety and Performance of the MicroPort's Transcatheter Aortic Valve and Delivery System for Treatment of Severe Aortic Stenosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02221921
• Other study ID #: U0000SYV
• Secondary ID: MicroPort Medica
• Status: Not yet recruiting
• Phase: N/A
• First received: August 14, 2014
• Last updated: August 20, 2014
• Start date: September 2014
• Est. completion date: September 2021

Study information

• Verified date: August 2014
• Source: Shanghai MicroPort Medical (Group) Co., Ltd.
• Contact: David Liu, Medical Doctor
• Phone: +86 13911002920
• Email: davidliu[@]coremed.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

1. Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve prosthesis and delivery system in intervention by peripheral artery.

2. The study Continuous observe 12 months of safety and efficacy. Approximately 89 patients are recruited in the study with native aortic valve stenosis which are considered unsuitable for Surgical Valve Replacement.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 89
• Est. completion date: September 2021
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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.

• Cerebrovascular Accident (CVA) within 6 months, including TIA (transient ischemic attack).

• Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.

• Life expectancy < 12 months

• Significant abdominal or thoracic aorta disease, including aneurysm, marked tortuosity (hyperacute bend), aortic arch atheroma, narrowing of the abdominal aorta (especially with calcification and surface irregularities), or severe "unfolding" and tortuosity of the thoracic aorta

• Iliofemoral vessel characteristics that would preclude safe placement of 16F to 19F introducer sheath such as severe obstructive calcification, severe tortuosity

• Active bacterial endocarditis or other active infections.

• Bulky calcified aortic valve leaflets in close proximity to coronary ostia

• severe incapacitating dementia.

• Currently participating in an investigational drug or another device study that has not reached its primary endpoint.

• Researchers identify that the patients with poor compliance who cannot be completed in accordance.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Calcification
• Aortic Valve Disease
• Aortic Valve Stenosis
• Calcinosis
• Heart Defects, Congenital
• Heart Valve Diseases

Intervention

Device:
• MicroPort's Transcatheter Aortic Valve and Delivery System

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort Medical (Group) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality or major stroke at 12 months.		12 months	Yes
Secondary	MACCE(major adverse cardiovascular and cerebrovascular events)	MACCE is defined as a composite of: Myocardial infarction (MI); Hemorrhage; renal failure; vascular complications; block; ventricular arrhythmias	30 days, 3, 6 and 12 months	Yes
Secondary	Device success	Device success is defined as; The device successfully enter the vascular approach, transport and release; The valve is placed in the correct anatomical position; The valve achieve the expected effect (mean aortic pressure < 20mmHg or peak velocity < 3m/s, with no severe aortic regurgitation or paravalvular leakage)	7 days post-operation	No
Secondary	Valve performance	Valve performance means: Transvalvular mean gradient; Effective orifice area; Degree of aortic valve regurgitation (transvalvular and paravalvular)	30 days, 3, 6 and 12 months	No
Secondary	The improvement of heart function		30 days, 3, 6 and 12 months	No