Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilo... | NCT02428010

Studies
Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

NCT02428010

Sponsor

Medtronic Cardiovascular

Status

Terminated

Last Update Posted

May 4, 2021Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Mitral Valve Insufficiency

Interventions

TMVR Implant

Countries

Poland

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Site has not reliably responded Medtronic team since the transition from sponsor Twelve. No data entry completed since February 2018. Last study subject passed final study visit window. No data is expected to be entered.

Expanded Access Info

Start Date

Sep 2014Actual

Primary Completion Date

Apr 2021Actual

Completion Date

Apr 2021Actual

First Submitted Date

Apr 23, 2015

First Submission Date that Met QC Criteria

Apr 27, 2015

First Posted Date

Apr 28, 2015Estimated

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

Apr 29, 2021

Last Update Posted Date

May 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	TMVR Implant	Device: TMVR Implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TMVR Implant	Device	Implantation of the Twelve TMVR System	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events	Number of patients with adverse events associated with the delivery and/or implantation of the device	30 days

Secondary Outcomes

Measure	Description	Time Frame
Procedural Success	Number of patients with successful TMVR implant	Through 5 years
Reduction of MR	Number of patients with a reduction of MR Grade

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sonia Diaz de Leon	Medtronic	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John Paul II Hospital		Krakow			Poland

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided