Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-29

Study Completion Date

2026-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)

NCT06591000

Allograft Bioprosthesis Tricuspid Valve Disease

RECRUITING

Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae

NCT03674593

Degenerative Mitral Valve Disease

ACTIVE_NOT_RECRUITING NA

Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

NCT03604484

Tricuspid Valve Insufficiency

COMPLETED NA

Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

NCT01580436

Tricuspid Valve Insufficiency

UNKNOWN NA

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

NCT02675244

Mild Tricuspid Regurgitation Moderate Tricuspid Regurgitation Tricuspid Regurgitation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with mid-term clinical efficacy ( mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication ) is going to be evaluated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allografts Tricuspid Valve Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with primary tricuspid valve insufficiency scheduled for tricuspid valve replacement

Mitral allograft implantation

Intervention Type PROCEDURE

Tricuspid valve replacement with mitral valve allograft

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mitral allograft implantation

Tricuspid valve replacement with mitral valve allograft

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.
* Intraoperative findings suggested for tricuspid valve replacement rather than repair.

Exclusion Criteria

* Pregnancy
* Confirmed active drug addiction
* Progressive HIV-infection
* HIV-infected patients with CD4-cells count less than 250
* Patients with secondary tricuspid valve pathology (left-sided valve disease)
* LV Ejection fraction less than 50%

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No