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Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population (LOTUS-CHINA)

Primary Purpose

Aortic Valve Stenosis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Lotus Valve System

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak systolic velocity of > 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope)
Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
Patients are technical and anatomical eligible for interventions

Exclusion Criteria:

A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
Subject refuses a blood transfusion.
Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging.
Life expectancy is less than one year

Sites / Locations

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lotus Valve System

Arm Description

Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System

Outcomes

Primary Outcome Measures

Combined rate of death from any cause, myocardial infarction, and stroke

Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)

Secondary Outcome Measures

Number of participants with procedural complications

Functional status (NYHA-classification)

Echocardiographic prosthesis status

Quality of Life (SF-12)

Full Information

NCT ID

NCT02536703

First Posted

August 27, 2015

Last Updated

August 27, 2015

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT02536703

Brief Title

Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population

Acronym

LOTUS-CHINA

Official Title

LOTUS-CHINA: Safety and Efficacy of Lotus Valve For Transcatheter Aortic Valve Implantation In Patients With Severe Aortic Stenosis In Chinese Population

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To confirm the safety and efficacy of the Lotus™ Valve System in the Chinese population for Transcatheter Aortic Valve Implantation (TAVI) in symptomatic patients with severe aortic stenosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lotus Valve System

Arm Type

Experimental

Arm Description

Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System

Intervention Type

Device

Intervention Name(s)

Lotus Valve System

Intervention Description

Lotus Valve System

Primary Outcome Measure Information:

Title

Combined rate of death from any cause, myocardial infarction, and stroke

Description

Outcome measures will be defined as suggested by the Valvular Academic Research Consortium (VARC)

Time Frame

30 days following procedure

Secondary Outcome Measure Information:

Title

Number of participants with procedural complications

Time Frame

30 days following procedure

Title

Functional status (NYHA-classification)

Time Frame

6 months following procedure

Title

Echocardiographic prosthesis status

Time Frame

6 months following procedure

Title

Quality of Life (SF-12)

Time Frame

6 months following procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with symptomatic severe aortic stenosis (echocardiographic criteria: AV effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak systolic velocity of > 4.0 m/s; NYHA-class II or greater, angina pectoris, or syncope) Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed. Patients are technical and anatomical eligible for interventions Exclusion Criteria: A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media Subject refuses a blood transfusion. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent. Native aortic annulus size < 20 mm or > 29 mm per the baseline diagnostic imaging. Life expectancy is less than one year

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xianbao Liu, MD

Phone

+86-13857173887

liuxb2009@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jian-an Wang, MD,PhD

Phone

+86-13805786328

Wang_jian_an@tom.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian-an Wang, MD,PhD

Organizational Affiliation

Second Affiliated Hospital Zhejiang University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

2nd Affiliated Hospital, School of Medicine at Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xianbao Liu, MD

Phone

+86-13857173887

liuxb2009@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population

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