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

NCT02536703 | Unknown Phase 3 DMC

• 1 other identifier: SAHZJU CT005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days following procedure

Secondary Outcomes (4)

• Number of participants with procedural complications

  30 days following procedure

• Functional status (NYHA-classification)

  6 months following procedure

• Echocardiographic prosthesis status

  6 months following procedure

• Quality of Life (SF-12)

  6 months following procedure

Study Arms (1)

Lotus Valve System

EXPERIMENTAL

Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System

Device: Lotus Valve System

Interventions

Lotus Valve System DEVICE

Lotus Valve System

Lotus Valve System

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

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, MD,PhD

  Second Affiliated Hospital Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianbao Liu, MD

CONTACT

+86-13857173887; liuxb2009@hotmail.com

Jian-an Wang, MD,PhD

CONTACT

+86-13805786328; Wang_jian_an@tom.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2020
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

CN (1)