Tricuspid Valve DiseaseNCT07761273
Tricuspid Valve Reconstruction Using the Right Atrial Appendage
A study testing Tricuspid Valve Reconstruction and tricuspid valve replacement in people with Tricuspid Valve Disease, run by Zagazig University at 3 sites in Egypt.
Trial summary
we use part of the cardiac chambre for replacement of destroyed valve on right side of the heart Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tricuspid Valve Disease
- What is being tested?
- Tricuspid Valve Reconstruction and tricuspid valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesEgypt
- Study dates
- 28 Apr 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patient need tricuspid valve replacement
Who cannot join
- patient refusal
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt3 sites
Amr El Sayed Tawfek
Zagazig, Sharqia Province, 44519
Amr Tawfek
Zagazig, Sharqia Province, 44519
cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt
Zagazig, Sharqia Province, 44519
About this study
we use part of the cardiac chambre for replacement of destroyed valve on right side of the heart
Read the detailed description
Tricuspid Valve Reconstruction Using the Right Atrial Appendage by harvesting appropriate size then reconstruction as bileaflet valve after reinforcement of the annulus by pericardial band then the neovalve fixed to papillary muscles of the right ventricle by artificial chorda anchored by teflon pledgets
- Conditions
- Tricuspid Valve Disease
- Being tested
- Tricuspid Valve Reconstruction, tricuspid valve replacement
- Keywords
- right atrial appendage -reconstruction-tricuspid valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricuspid Valve ReconstructionProcedure or surgery
Tricuspid Valve Reconstruction using right atrial appendage
tricuspid valve replacementProcedure or surgery
tricuspid valve replacement using tissue valve
| Study group | Role | What they receive |
|---|---|---|
| right atrial appendage | Experimental | right atrial appendage used for tricuspid valve reconstruction Receives: Procedure: Tricuspid Valve Reconstruction |
| tissue valve | Active comparator | tissue valve used for tricuspid valve replacement Receives: Procedure: tricuspid valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
perioperative and short-term mortality, with no major procedure-related surgical complication
Measured: 30 day post operative
Morbidity
Measured: 30 day post operative
measuring pressure gradient
Follow-up echocardiography by measuring pressure gradient across the neo valve
Measured: 6 months postoperative
Thromboembolic Risk checklist
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start28 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr Elsayed Tawfek Ibrahim, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761273
- Sponsor's protocol ID
- ZU-2254/28-April-2026
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tricuspid Valve Reconstruction Using the Right Atrial Appendage
- ClinicalTrials.gov ID
- NCT07761273
- Acronym / sponsor ID
- ZU-2254/28-April-2026
- Conditions
- Tricuspid Valve Disease
- Keywords
- right atrial appendage -reconstruction-tricuspid valve
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
we use part of the cardiac chambre for replacement of destroyed valve on right side of the heart
Detailed description
Tricuspid Valve Reconstruction Using the Right Atrial Appendage by harvesting appropriate size then reconstruction as bileaflet valve after reinforcement of the annulus by pericardial band then the neovalve fixed to papillary muscles of the right ventricle by artificial chorda anchored by teflon pledgets
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| right atrial appendage | Experimental | Procedure: Tricuspid Valve Reconstructionright atrial appendage used for tricuspid valve reconstruction |
| tissue valve | Active comparator | Procedure: tricuspid valve replacementtissue valve used for tricuspid valve replacement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patient need tricuspid valve replacement
Key exclusion criteria (1 listed)
- patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tricuspid Valve ReconstructionTricuspid Valve Reconstruction using right atrial appendage | Procedure or surgery | right atrial appendage |
| tricuspid valve replacementtricuspid valve replacement using tissue valve | Procedure or surgery | tissue valve |
Primary outcome
Mortality
Time frame: 30 day post operative
perioperative and short-term mortality, with no major procedure-related surgical complication
Morbidity
Time frame: 30 day post operative
measuring pressure gradient
Time frame: 6 months postoperative
Follow-up echocardiography by measuring pressure gradient across the neo valve
Thromboembolic Risk checklist
Time frame: 6 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes
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Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
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The TRICURE US IDE Pivotal Study
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EFS of the DUO System for Tricuspid Regurgitation
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TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
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Recruiting
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tricuspid Valve Reconstruction and tricuspid valve replacement in people with Tricuspid Valve Disease, run by Zagazig University at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 day post operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.