TriRec

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

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2030-01-31

Brief Summary

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

Reconstruction of the aortic valve using the tri-leaflet repair technique is non-inferior with regard to effective orifice area (EOA) to surgical aortic valve replacement (SAVR) with a biological prosthesis (St. Jude Trifecta GT) as gold- standard.

Related Clinical Trials

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

TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

NCT05536310

Aortic Valve Stenosis Aortic Valve Regurgitation Aortic Valve Stenosis With Insufficiency +6 more

NOT_YET_RECRUITING

TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

NCT02981953

Tricuspid Valve Insufficiency Tricuspid Regurgitation Tricuspid Valve Regurgitation +4 more

COMPLETED NA

Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.

NCT05836415

Functional Tricuspid Regurgitation

COMPLETED

Aortic Valve Replacement With Trifecta(TM)

NCT00475267

Aortic Valve Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence +1 more

COMPLETED NA

German Registry for Transcatheter Tricuspid Valve Interventions

NCT04653428

Tricuspid Regurgitation Tricuspid Valve Insufficiency Heart Valve

RECRUITING

Detailed Description

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

Conditions

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

Alternative Surgical Treatment for Aortic Valve Disease

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Trileaflet Reconstruction of the Aortic Valve

Group Type EXPERIMENTAL

TriRec

Intervention Type OTHER

Trileaflet Reconstruction of the Aortic Valve

Aortic valve replacement

Biological prosthesis, Device: St. Jude Medical Trifecta GT

Group Type EXPERIMENTAL

Aortic valve replacement

Intervention Type OTHER

Biological Prosthesis, Device: St. Jude Medical Trifecta GT

Interventions

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

TriRec

Trileaflet Reconstruction of the Aortic Valve

Intervention Type OTHER

Aortic valve replacement

Biological Prosthesis, Device: St. Jude Medical Trifecta GT

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Age \>= 50 years
* Documented symptomatic moderate or greater aortic stenosis or severe insufficiency
* Aortic annulus \> 19 mm
* Written informed consent of the patient.

Exclusion Criteria

* Concomitant intervention of the aortic root
* Concomitant intervention of the aortic arch
* Concomitant valve surgery
* Emergency surgery for any reason
* Neurological events (i.e. stroke, TIA) within 6 months preoperatively
* Coagulation disorders (including thrombocytopenia \< 100.000/ml)
* Porcelain aorta
* Active endocarditis or other active systemic infections
* Participating in another trial that may influence the outcome of this trial
* Pregnancy
* Dual antiplatelet therapy
* Previous cardiac surgery (excluding percutaneous procedures)

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No