Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Valve Regurgitation
- Sponsor
- Mitralix
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- • Safety
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR).
The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
Detailed Description
The main objectives of this study are to evaluate safety and effectiveness of the Mistral implant for the percutaneous treatment of patients with symptomatic moderate or greater tricuspid regurgitation (TR) who are at high risk for tricuspid valve surgery. Primary endpoints: * Safety: Incidence of Major Device Related Adverse Events (MDRAE). \[Time frame: 6 months\]. * Efficacy: Echocardiographic improvement in TR severity of at least 1 grade \[Time Frame: 30 days\]. Secondary endpoints: Safety: * Incidence of Major Device Related Adverse Events (MDRAE). \[Time Frame: 1, 6, 12, and 24 months\]. * Incidence of device or procedure related serious adverse events \[Time Frame: 30 days\]. Efficacy: • Change in TR grade by Echocardiography \[Time Frame: 1, 6, 12, and 24 months over baseline\].
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
- •Subject is ≥ 18 years of age or legal age in host country
- •Minimum of moderate functional or degenerative tricuspid regurgitation:
- •Subjects with moderate TR: Only NYHA (New York Heart Association) Class III or IV maybe considered for inclusion.
- •Subjects with severe or greater TR: NYHA (New York Heart Association) Class II, III, or IV may be considered for inclusion
- •Subject has left ventricular ejection fraction (LVEF) \>20 %
- •The subject is at high risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon and an interventional cardiologist at the site (center heart team).
- •Femoral or Jugular access of the Steerable Catheter with MDS (Mistral Delivery System) is determined to be feasible.
- •Subject must agree not to start participating in any other clinical trial for a period of 6 months following the index procedure.
- •As determined by the center heart team, the Mistral is the suitable treatment option.
Exclusion Criteria
- •Tricuspid Stenosis \>mild
- •Tricuspid Sub valvular calcification or calcification of the chordae.
- •Subjects with Mitral valve severe stenosis and/or severe regurgitation.
- •Previous tricuspid valve repair or replacement that would interfere with placement of Mistral
- •Subjects with severe, uncontrolled hypertension.
- •Subjects, which need to undergo an emergency surgery.
- •Subject is currently participating in another clinical trial that has not yet completed its primary endpoints.
- •Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 30 days.
- •Subject has a history of a myocardial infarction (MI) in the past 30 days.
- •Subject has had a percutaneous coronary intervention (PCI), within the last 30 days before procedure.
Outcomes
Primary Outcomes
• Safety
Time Frame: 6 months
Incidence of Major Device Related Adverse Events (MDRAE).
Secondary Outcomes
- Safety - Incidence of device or procedure related serious adverse events(30 days)
- Effectiveness TR(1, 6, 12, and 24 months over baseline)
- Safety - Incidence of Major Device Related Adverse Events(1, 6, 12, and 24 months)