Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System

Mitral Valve Regurgitation Clinical Trial

— TIARA-I  

Official title:

Early Feasibility Study of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02276547
• Other study ID #: 047-CPT-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Neovasc Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: February 2025
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Mitral valve replacement
Transcatheter mitral valve replacement

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerpen
Canada	University of Alberta	Edmonton	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	Northwestern University	Chicago	Illinois
United States	Henry Ford Health System	Detroit	Michigan
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Columbia University Medical Center	New York	New York
United States	Washington University	Saint Louis	Missouri
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Neovasc Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

References & Publications (3)

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. — View 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. — View 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. Erratum In: J Thorac Cardiovasc Surg. 2014 Oct 21;64(16):1763. Dosage error in article text. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom From All-cause Mortality and Major Adverse Events	Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention	From the time of implant procedure to 30 days or hospital discharge (whichever is later)
Secondary	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		30 days, 90 days, 180 days and annually to five years
Secondary	Individual 30 Day Rates of Device and Procedure Related Major Adverse Events	All mortality; All stroke; Residual MR > mild (1+); Life threatening bleeding; Acute kidney injury Grade 3; New pacemaker/LBBB; Coronary occlusion/myocardial infarction; Urgent/emergent surgery or reintervention	30 days
Secondary	Number and Percentage of Subjects With Progression of Heart Failure	Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation	One year
Secondary	Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter	Mitral regurgitation < moderate (2+) Effective valve orifice area = 1.5 cm2 as assessed by post-procedural echocardiogram Mitral Valve gradient < 5 mmHg No migration No fracture No endocarditis Stroke free No additional valve/access related interventional or surgical procedures	Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years
Secondary	Performance	Clinical performance as measured by NYHA Functional Class, 6MWT, and the KCCQ Hemodynamic performance as assessed by echocardiography: mean MV gradient, mitral regurgitation, effective orifice area of the MV, LV systolic and diastolic dimensions as well as volume Stroke free survival Original intended device in place No additional valve/access-related interventional or surgical procedures	30 days, 90 days, 180 days and annually for five years
Secondary	Days Alive and Out of Hospital	Number of days alive and not hospitalized	At one year

External Links

•   Company website with product information