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Clinical Trials/NCT07761273
NCT07761273Enrolling By InvitationNot Applicable

Tricuspid Valve Reconstruction Using the Right Atrial Appendage

Zagazig University3 sites in 1 country30 target enrollmentStarted: April 28, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
30
Locations
3
Primary Endpoint
Mortality

Study Overview

Brief Summary

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •all patient need tricuspid valve replacement

Exclusion Criteria

  • •patient refusal

Arms & Interventions

right atrial appendage

Experimental

right atrial appendage used for tricuspid valve reconstruction

Intervention: Tricuspid Valve Reconstruction (Procedure)

tissue valve

Active Comparator

tissue valve used for tricuspid valve replacement

Intervention: tricuspid valve replacement (Procedure)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Amr Elsayed Tawfek Ibrahim

assistant prof

Zagazig University

Study Sites (3)

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