Status unknownNCT02536703LOTUS-CHINAUpdated Sep 1, 2015

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

A Phase 3 interventional study of Lotus Valve System in Aortic Valve Stenosis, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2015-09-01.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 65 Years and older
Sex: All

Study 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 studied

Aortic Valve Stenosis

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In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

Experimental
Lotus Valve System
Transcatheter Aortic Valve Implantation (TAVI) with Lotus Valve System
Device: Lotus Valve System

Interventions

DeviceLotus Valve System
Lotus Valve System

What researchers measure

Primary outcomes

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)
Time frame: 30 days following procedure

Secondary outcomes

Number of participants with procedural complications
Time frame: 30 days following procedure
Functional status (NYHA-classification)
Time frame: 6 months following procedure
Echocardiographic prosthesis status
Time frame: 6 months following procedure
Quality of Life (SF-12)
Time frame: 6 months following procedure

Study locations

1 site

2nd Affiliated Hospital, School of Medicine at Zhejiang University
Hangzhou, Zhejiang 310009, China
- Xianbao Liu, MD · Contact · liuxb2009@hotmail.com · +86-13857173887

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02536703
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party: Jian'an Wang,MD,PhD (President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University) — Principal investigator
First posted: Sep 1, 2015
Start date: Sep 2015
Primary completion: Dec 2015 (estimated)
Completion: Dec 2020 (estimated)
Last update: Sep 1, 2015

Study contacts

Xianbao Liu, MD

Contact

liuxb2009@hotmail.com

+86-13857173887

Jian-an Wang, MD,PhD

Contact

Wang_jian_an@tom.com

+86-13805786328

Jian-an Wang, MD,PhD

principal investigator · Second Affiliated Hospital Zhejiang University School of Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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