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Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Twelve, Inc.
Sponsor:
Information provided by (Responsible Party):
Twelve, Inc.
ClinicalTrials.gov Identifier:
NCT02428010
First received: April 23, 2015
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
Study to evaluate the safety and performance of the Twelve TMVR System

Condition Intervention
Mitral Valve Insufficiency Device: TMVR Implant

Study Type: Interventional
Study Design: 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

Further study details as provided by Twelve, Inc.:

Primary Outcome Measures:
  • 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:
  • Procedural Success [ Time Frame: Through 5 years ]
    Number of patients with successful TMVR implant

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


Estimated Enrollment: 10
Study Start Date: September 2014
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
TMVR Implant
Device: TMVR Implant
Implantation 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Responsible Party: Twelve, Inc.
ClinicalTrials.gov Identifier: NCT02428010     History of Changes
Other Study ID Numbers: CIP-1402
Study First Received: April 23, 2015
Last Updated: October 26, 2016

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

ClinicalTrials.gov processed this record on September 21, 2017