Clinical trial NCT02276547: Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
Official title: Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mitral Valve Regurgitation
Keywords: Mitral
Regurgitation
Heart valve
Transcatheter
Transapical
Functional
Degenerative
Symptomatic, severe mitral valve regurgitation, high risk for open mitral valve surgery
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

Detailed description: This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who are at high risk for open chest surgery.

A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum of 15 subjects will be implanted in the United States.

Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a transcatheter mitral valve replacement (TMVR) procedure.

Eligibility criteria: Inclusion Criteria:

* Severe symptomatic mitral regurgitation (Stage D)
* High surgical risk for open mitral valve surgery
* Subject meets the anatomical eligibility criteria for available size(s)
* NYHA Class III or IV heart failure

Exclusion Criteria:

* DMR deemed by the heart team to be operable.
* Prohibitive risk, deemed too frail or listed for cardiac transplant.
* Unsuitable cardiac structure

Primary outcomes:
measure: Freedom From All-cause Mortality and Major Adverse Events
timeFrame: From the time of implant procedure to 30 days or hospital discharge (whichever is later)
Secondary outcomes:
measure: Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
timeFrame: 30 days, 90 days, 180 days and annually to five years
measure: Individual 30 Day Rates of Device and Procedure Related Major Adverse Events
timeFrame: 30 days
measure: Number and Percentage of Subjects With Progression of Heart Failure
timeFrame: One year
measure: Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter
timeFrame: Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years
measure: Performance
timeFrame: 30 days, 90 days, 180 days and annually for five years
measure: Days Alive and Out of Hospital
timeFrame: At one year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of British Columbia
name: Anson Cheung, MD
role: STUDY_CHAIR
References:
citation: De Backer O, Piazza N, Banai S, Lutter G, Maisano F, Herrmann HC, Franzen OW, Sondergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014 Jun;7(3):400-9. doi: 10.1161/CIRCINTERVENTIONS.114.001607. No abstract available.
citation: Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. No abstract available.
citation: Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.