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Not yet recruitingNCT06067815Updated Oct 5, 2023

Assessment of Right Ventricular Function in Patients With Severe Mitral Stenosis Before and After Balloon Mitral Valvuloplasty

An observational study in Mitral Stenosis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
16 Years to 70 Years
Sex
All
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Study summary

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

Read the detailed description

In patients with mitral valve stenosis, right ventricular failure may develop either by the rheumatic process directly or through hemodynamic alterations resulting from pulmonary vascular changes.

Right ventricular (RV) function plays an important role in development of clinical symptoms and prognosis in patients with mitral stenosis (MS).This is primarily affected by hemodynamic effects on RV due to pulmonary hypertension(PH).

In the last two decades, Percutaneous Transluminal Mitral Commissurotomy (PTMC) has become the treatment of choice for patients with symptomatic rheumatic MS . Using this method,Mitral Valve Area (MVA) can be increased, which can improve the hemodynamic and clinical features of patients with MS .

RV functional assessment is difficult and not done routinely because of its complex anatomy and high load dependence.

Different modalitis are used to assess RV function as Tissue Doppler and two-dimensional (2D) speckle tracking method has been used to quantify strain for assessment Myocardial strain is a measure of tissue deformation, which is expressed as a percentage change.

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Conditions studied

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In context

Mitral Valve Stenosis

58 studies on the registry are indexed under Mitral Valve Stenosis; 21 are open to participants now.

This study's planned enrollment of 30 is below the median of 301 across 21 observational studies indexed under Mitral Valve Stenosis.

Browse Mitral Valve Stenosis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with severe mitral stenosis,not impairment left ventricular function

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. To compare RV function before and after PTMC

    echocardiogram

    Time frame: 1 year

Secondary outcomes

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

    Right sided heart catheterization

    Time frame: 1 year

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

    Time frame: 1year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 24814111 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06067815
Lead sponsor
Assiut University
Responsible party
Yassmin Zakaria Basheir (Assessment of right ventricular function in patient with severe mitral stenosis before and after balloon mitral valvuloplasty, Assiut University) — Principal investigator
First posted
Oct 5, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Oct 1, 2024 (estimated)
Completion
Nov 1, 2024 (estimated)
Last update
Oct 5, 2023

Study contacts

Yassmin Zakaria Basheir
Contact
Yass.min97@yahoo.com
01115429471
Hamdy Shams-eddin Mohammad, Professor
Contact
ashams98@yahoo.com
01065601161

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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