Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

Mitral Valve Insufficiency Clinical Trial

Official title:

Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02428010
• Other study ID #: CIP-1402
• Status: Terminated
• Phase: N/A
• Start date: September 2014
• Est. completion date: April 2021

Study information

• Verified date: April 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Intervention

Device:
• TMVR Implant
Implantation of the Twelve TMVR System

Locations

Country	Name	City	State
Poland	John Paul II Hospital	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of patients with adverse events associated with the delivery and/or implantation of the device	30 days
Secondary	Procedural Success	Number of patients with successful TMVR implant	Through 5 years
Secondary	Reduction of MR	Number of patients with a reduction of MR Grade	Through 5 years