NCT02428010

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 4, 2021

Status Verified

April 1, 2021

Enrollment Period

6.6 years

First QC Date

April 23, 2015

Last Update Submit

April 29, 2021

Conditions

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

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

    30 days

Secondary Outcomes (2)

  • Procedural Success

    Through 5 years

  • Reduction of MR

    Through 5 years

Study Arms (1)

Treatment

EXPERIMENTAL

TMVR Implant

Device: TMVR Implant

Interventions

TMVR ImplantDEVICE

Implantation of the Twelve TMVR System

Treatment

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Paul II Hospital

Krakow, Poland

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Sonia Diaz de Leon

    Medtronic

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

September 1, 2014

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

May 4, 2021

Record last verified: 2021-04

Locations

PL(1)