NCT06067815

Brief Summary

To detect short-term impacts of successful balloon mitral valvuloplasty on right ventricular function

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Status
unknown

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

First Submitted

Initial submission to the registry

September 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 5, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 28, 2023

Last Update Submit

September 28, 2023

Conditions

Mitral Stenosis

Outcome Measures

Primary Outcomes (1)

  • To compare RV function before and after PTMC

    echocardiogram

    1 year

Secondary Outcomes (2)

  • To measure the right side pressure changes invasively before and after PTMC

    1 year

  • To compare the effect of PTMC on RV function in patient with AF and sinus rythm

    1year

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe mitral stenosis,not impairment left ventricular function

You may qualify if:

  • Patient with isolated mitral stenosis (except those with mild mitral regurgitation and are candidate for PTMC by 2D Echo evaluation).
  • Patient with normal left ventricular EF.
  • patient with sinus rhythm or AF
  • patient with any degree of pulmonary HTN

You may not qualify if:

  • Patient with another valve lesion or more than mild mitral regurgitation.
  • Patient with impaired cardiac function.
  • patient with coronary arteries disease
  • Mitral stenosis of other etiology than rheumatic origin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kumar V, Jose VJ, Pati PK, Jose J. Assessment of right ventricular strain and strain rate in patients with severe mitral stenosis before and after balloon mitral valvuloplasty. Indian Heart J. 2014 Mar-Apr;66(2):176-82. doi: 10.1016/j.ihj.2014.02.012. Epub 2014 Mar 1.

    PMID: 24814111BACKGROUND

MeSH Terms

Conditions

Mitral Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Yassmin Zakaria Basheir

CONTACT

01115429471Yass.min97@yahoo.com

Hamdy Shams-eddin Mohammad, Professor

CONTACT

01065601161ashams98@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assessment of right ventricular function in patient with severe mitral stenosis before and after balloon mitral valvuloplasty

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 5, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

October 5, 2023

Record last verified: 2023-09