Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

Medtronic Cardiovascular3 enrolled

Overview

Study to evaluate the safety and performance of the Twelve TMVR System

The study is a prospective, multi-center, non-randomized trial to evaluate the safety and performance of the Twelve TMVR System in very high risk patients with severe, symptomatic mitral regurgitation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Valve Insufficiency

Interventions

TMVR ImplantDEVICE

Implantation of the Twelve TMVR System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Severe mitral regurgitation (MR Grade 3-4+) * Symptomatic mitral regurgitation (NYHA Class II-IV) * Trans-apical access deemed feasible by the treating physician * Native mitral valve geometry and size compatible with the Twelve TMVR Key Exclusion Criteria: * Left ventricular ejection fraction (LVEF) \< 20 * Evidence of intracardiac mass, thrombus, or vegetation * Prior valve surgery or need for other valve surgery * Prior stroke within 4 weeks * Need for coronary revascularization * History of, or active, endocarditis * Renal insufficiency (Creatinine \> 2.5 mg/dL)

Locations (1)

John Paul II Hospital

Krakow, Poland

Outcomes

Primary Outcomes

Adverse Events

Number of patients with adverse events associated with the delivery and/or implantation of the device

Time frame: 30 days

Secondary Outcomes

Procedural Success

Number of patients with successful TMVR implant

Time frame: Through 5 years

Reduction of MR

Number of patients with a reduction of MR Grade

Time frame: Through 5 years

Data from ClinicalTrials.gov

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