NCT04954404

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
60mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
May 2021May 2031

Study Start

First participant enrolled

May 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Expected
Last Updated

July 8, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

June 20, 2021

Last Update Submit

June 29, 2021

Conditions

Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

  • Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.

    Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.

    30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years

Secondary Outcomes (36)

  • All-cause mortality

    Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years

  • Cardiovascular mortality

    Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years

  • Rehospitalization related to heart failure

    30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years

  • Stroke

    Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years

  • Transient ischemic attack

    Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years

  • +31 more secondary outcomes

Study Arms (1)

Transcatheter mitral valve repair/replacement

EXPERIMENTAL
Device: transcatheter mitral valve repair/transcatheter mitral valve replacement

Interventions

transcatheter mitral valve repair/transcatheter mitral valve replacementDEVICE

transcatheter mitral valve repair/transcatheter mitral valve replacement

Transcatheter mitral valve repair/replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mitral valve disease, as determined by the site from a transthoracic echocardiogram (TTE), and in the judgment of the investigator intervention is likely to provide clinical benefit for the patient.
  • 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:

  • In the judgment of the investigator, subjects are not anatomical eligible for interventions.
  • Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
  • Active endocarditis or active rheumatic heart disease.
  • History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
  • Subject has any kind of conditions that might prevent patients benefiting from therapeutic benefit (i.e., Severe mental illness) or life expectancy is less than one year.
  • Subject has any kind of disorder per investigator's judgement that compromises his/her ability to give written informed consent and/or to comply with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine.

Hangzhou, Zhejiang, 310006, China

RECRUITING

Related Publications (1)

  • Pu Z, Yu T, Liu X, Lin X, Li H, Lim DS, Wang J. A modified Carpentier classification in transcatheter edge-to-edge repair for mitral regurgitation. Catheter Cardiovasc Interv. 2024 Oct;104(4):870-877. doi: 10.1002/ccd.31158. Epub 2024 Jul 24.

    PMID: 39049480DERIVED

Study Officials

  • Jian'an Wang, PhD, MD

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    STUDY CHAIR

Central Study Contacts

Jian'an Wang, PhD, MD

CONTACT

+86057187783777wja@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Transcatheter mitral valve repair/Transcatheter mitral valve replacement
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2021

First Posted

July 8, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2022

Study Completion (Estimated)

May 1, 2031

Last Updated

July 8, 2021

Record last verified: 2021-05

Locations

CN(1)