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Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

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ClinicalTrials.gov Identifier: NCT02428010
Recruitment Status : Recruiting
First Posted : April 28, 2015
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Twelve, Inc.

Brief Summary:
Study to evaluate the safety and performance of the Twelve TMVR System

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Device: TMVR Implant Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Performance of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Severe, Symptomatic Mitral Regurgitation
Study Start Date : September 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2023

Arm Intervention/treatment
Experimental: Treatment
TMVR Implant
Device: TMVR Implant
Implantation of the Twelve TMVR System




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 30 days ]
    Number of patients with adverse events associated with the delivery and/or implantation of the device


Secondary Outcome Measures :
  1. Procedural Success [ Time Frame: Through 5 years ]
    Number of patients with successful TMVR implant

  2. Reduction of MR [ Time Frame: Through 5 years ]
    Number of patients with a reduction of MR Grade



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428010


Contacts
Contact: Craig Straley 650-503-5724 cstraley@twelvemed.com

Locations
Poland
John Paul II Hospital Recruiting
Krakow, Poland
Contact: Krzysztof Bartus, MD, PhD    +48 50 2294350    cool_chris@interial.pl   
Sponsors and Collaborators
Twelve, Inc.
Investigators
Study Director: Craig Straley Twelve, Inc.

Responsible Party: Twelve, Inc.
ClinicalTrials.gov Identifier: NCT02428010     History of Changes
Other Study ID Numbers: CIP-1402
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases