Early Safety and Clinical Efficacy of Mitral Allograft in... | NCT06196684

Studies
Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery

NCT06196684

Sponsor

Chelyabinsk Regional Clinical Hospital

Status

Active, not recruiting

Last Update Posted

Oct 6, 2025Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Allografts
Tricuspid Valve Insufficiency

Interventions

Mitral allograft implantation

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2021Actual

Primary Completion Date

Sep 29, 2026Estimated

Completion Date

Oct 30, 2026Estimated

First Submitted Date

Dec 26, 2023

First Submission Date that Met QC Criteria

Dec 26, 2023

First Posted Date

Jan 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2025

Last Update Posted Date

Oct 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mikhail Nuzhdin, Director, Chelyabinsk Regional Clinical HospitalPrincipal Investigator

Lead Sponsor

Chelyabinsk Regional Clinical HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with primary tricuspid valve insufficiency scheduled for tricuspid valve replacement			Procedure: Mitral allograft implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mitral allograft implantation	Procedure	Tricuspid valve replacement with mitral valve allograft	Patients with primary tricuspid valve insufficiency scheduled for tricuspid valve replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality (all cause and valve-related)	Estimate rate of mortality (all cause and valve-related)	30-day period

Secondary Outcomes

Measure	Description	Time Frame
Neurologic events	any neurological events in 30-day period	30-day period
Bleeding and transfusions	Freedom from major bleeding events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with primary tricuspid valve disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiac Surgery		Chelyabinsk	Chelyabinsk Oblast	454076	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided