NCT07761273

Brief Summary

we use part of the cardiac chambre for replacement of destroyed valve on right side of the heart

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Apr 2026

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

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

Study Progress32%
Apr 2026Apr 2027

Study Start

First participant enrolled

April 28, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 3, 2026

Last Update Submit

August 11, 2026

Conditions

Tricuspid Valve Disease

Keywords

right atrial appendage -reconstruction-tricuspid valve

Outcome Measures

Primary Outcomes (4)

  • Mortality

    perioperative and short-term mortality, with no major procedure-related surgical complication

    30 day post operative

  • Morbidity

    30 day post operative

  • measuring pressure gradient

    Follow-up echocardiography by measuring pressure gradient across the neo valve

    6 months postoperative

  • Thromboembolic Risk checklist

    6 months postoperative

Study Arms (2)

right atrial appendage

EXPERIMENTAL

right atrial appendage used for tricuspid valve reconstruction

Procedure: Tricuspid Valve Reconstruction

tissue valve

ACTIVE COMPARATOR

tissue valve used for tricuspid valve replacement

Procedure: tricuspid valve replacement

Interventions

Tricuspid Valve ReconstructionPROCEDURE

Tricuspid Valve Reconstruction using right atrial appendage

right atrial appendage
tricuspid valve replacementPROCEDURE

tricuspid valve replacement using tissue valve

tissue valve

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patient need tricuspid valve replacement

You may not qualify if:

  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Amr El Sayed Tawfek

Zagazig, Sharqia Province, 44519, Egypt

Location

Amr Tawfek

Zagazig, Sharqia Province, 44519, Egypt

Location

cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt

Zagazig, Sharqia Province, 44519, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant prof

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 12, 2026

Study Start

April 28, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(3)