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Status unknownNCT05566340Updated Oct 4, 2022

Treatment of Moderate FMR During AVR

An observational study in Functional Mitral Regurgitation, sponsored by Fuwai Yunnan Cardiovascular Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-04.

Sponsored by Fuwai Yunnan Cardiovascular Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
154
Ages
18 Years and older
Sex
All
01

Study summary

Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease. This study aims to evaluate the left ventricular function, which was evaluated through global longitudinal strain, after isolated AVR and AVR + mitral valve repair (MVr) in this group of patients.

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Conditions studied

  • Functional Mitral Regurgitation

Keywords

  • functional mitral regurgitation
  • aortic valve replacement
  • mitral valve repair
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In context

Mitral Valve Insufficiency

459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.

This study's planned enrollment of 154 is close to the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.

Browse Mitral Valve Insufficiency studies →

Lead sponsor

Fuwai Yunnan Cardiovascular Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A total of 154 patients with moderate FMR undergoing isolated AVR or AVR + MVr will be prospectively enrolled.

Inclusion criteria

  1. Patients who received AVR (with or without concomitant MVr) from two center (Fuwai Yunnan Cardiovascular Hospital and Fuwai Hospital, Chinese Academy of Medical Sciences).
  2. Age more than 18 years.

Exclusion criteria

Exclusion Criteria:

  1. Those with a history of rheumatic valvular disease or infective endocarditis.
  2. Primary mitral valve lesions.
  3. Patients receiving mitral valve replacement.
  4. Patient who refuse to participate in this study, or cannot complete 6-month follow-up after surgery.
  5. Age \< 18 years.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
154 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • isolated aortic valve replacement group

    Isolated aortic valve replacement surgery.

    Procedure: mitral valve repair

  • aortic valve replacement with mitral valve repair group

    Aortic valve replacement with mitral valve repair

    Procedure: mitral valve repair

Interventions

  • Proceduremitral valve repair

    Repair of mitral valve concomitant to aortic valve replacement.

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What researchers measure

Primary outcomes

  1. left ventricular global longitudinal strain

    The change of left ventricular global longitudinal strain compared to before surgery

    Time frame: 10/10/2022-10/10/2023

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05566340
Lead sponsor
Fuwai Yunnan Cardiovascular Hospital
Responsible party
Sponsor
First posted
Oct 4, 2022
Start date
Oct 2022 (estimated)
Primary completion
Oct 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Oct 4, 2022

Study contacts

Xieraili Tiemuerniyazi
Contact
tiemuernyz@mail2.sysu.edu.cn
+86-18814115887

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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