ClinicalTrials.gg
Sign In
Enrolling by invitationNCT07936734Updated Nov 13, 2026

Operative Tricuspid Annular Plane Systolic Excursion (TAPSE) as a Predictor for Early Outcome of Mitral Valve Replacement and Tricuspid Repair for Rheumatic Mitral Valve Disease

An observational study in Tricuspid Annular Plane Systolic Excursion (TAPSE), sponsored by Zagazig University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Zagazig University · Observational

Updated Nov 13, 2026Newly registeredGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
130
Ages
18 Years to 70 Years
Sex
All
01

Study summary

is one preoperative echo measure considered prognostic factor on the post operative result on diseased mitral and tricuspid valve surgery

Read the detailed description

preoperative TAPSE can be used as a predictor for early outcome of mitral valve replacement associated with tricuspid repair in rheumatic mitral valve disease Prospective observational comparative study.

Patients will be divided into two groups according to the preoperative TAPSE value, Group A (Normal TAPSE), whom have a TAPSE value more than 16mm, and Group B (Reduced TAPSE), whom have TAPSE value equal or less than 16 mm.

02

Conditions studied

  • Tricuspid Annular Plane Systolic Excursion (TAPSE)

Keywords

  • tricuspid annular plane systolic excursion (TAPSE)
  • mitral valve replacement
  • tricuspid repair
  • rheumatic mitral valve disease
03

In context

Lead sponsor

Zagazig University is the lead sponsor of 461 studies on the registry; 78 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Zagazig University studies →

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with rheumatic mitral valve disease with tricuspid valve regurgitation indicated for elective MV replacement and tricuspid repair.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with rheumatic mitral valve disease with tricuspid valve regurgitation indicated for elective MV replacement and tricuspid repair.

Exclusion criteria

Exclusion Criteria:

    • Patients operated in emergency.

      • Patients with aortic or pulmonary valve disease who needed intervention.
      • Tricuspid valve or mitral valve surgery alone.
      • Patients who underwent associated coronary artery bypass surgery.
      • Patients with congenital heart disease.
      • Hepatic failure patients.
      • patients.
      • Renal impairment patients.
      • Patients have blood disease.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
130 participants (estimated)
Target follow-up
112 Months
Patient registry
Yes

Groups and cohorts

  • Group A (Normal TAPSE),

    whom have a TAPSE value more than 16mm

    Procedure: mitral valve replacement, tricuspid valve repair

  • Group B (Reduced TAPSE)

    whom have TAPSE value equal or less than 16 mm

    Procedure: mitral valve replacement, tricuspid valve repair

Interventions

  • Proceduremitral valve replacement, tricuspid valve repair

    mitral valve replacement by metallic or tissue valve, tricuspid valve repair by devega, pericardial band or annuplasty ring

06

What researchers measure

Primary outcomes

  1. Intraoperative data,

    Cross clamp time.( min) add, By pass time. (min)

    Time frame: during time of operation

  2. postoperative ICU variables

    The type and duration for postoperative inotropic, adrenaline ,noradrenaline ,milrinone and dobutamine ,. (hours) add, Mechanical ventilation time. (hours) add, Blood transfusion, RBC and Plasma. (units) add ,Intensive care unit (ICU) stay (days)

    Time frame: during time of ICU stay

  3. hospital stay

    hospital stay (day)

    Time frame: 30 days

Secondary outcomes

  1. follow up

    echo measuring-TAPSE-ejection fraction, tricuspid valve pressure gradient

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 13, 2026
StartEst.
Nov 2026
Primary completionEst.
Apr 2027
CompletionEst.
May 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07936734
Lead sponsor
Zagazig University
Responsible party
Amr Elsayed Tawfek Ibrahim (assistant pro of cardiothoracic surgery, Zagazig University) — Principal investigator
First posted
Nov 13, 2026
Start date
Nov 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Nov 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Zagazig University →

Start the discussion