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Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study (TRIBUTE)

Primary Purpose

Tricuspid Valve Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Mistral Procedure
Sponsored by
Mitralix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Valve Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Subject with active endocarditis. Subject has echocardiographic evidence of intra-cardiac mass, thrombus, vegetation or soft-mobile deposits. Subject has hemodynamic instability requiring inotropic or mechanical support. Subject has a known hypersensitivity or contraindication to anticoagulant and antiplatelet medication. Subject is on chronic dialysis. Bleeding disorders or hypercoagulable state. In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding. Subject has a known allergy to Nitinol alloys, 316L\304 stainless steel. Pregnant or lactating women. Patients being dependent upon the sponsor or upon the investigator or upon the investigational site. According to investigator on site the patient is suffering from a severe end stage disease (e.g. malignancy, severe pulmonary disease, liver disease, renal failure). Contraindication for TEE (transesophageal echocardiography) including trans-gastric views. Life expectancy of less than 1 year

Sites / Locations

  • Wolfson Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mistral device

Arm Description

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.

Outcomes

Primary Outcome Measures

• Safety
Incidence of Major Device Related Adverse Events (MDRAE).

Secondary Outcome Measures

Safety - Incidence of Major Device Related Adverse Events
Incidence of Major Device Related Adverse Events (MDRAE).
Safety - Incidence of device or procedure related serious adverse events
Incidence of device or procedure related serious adverse events
Effectiveness TR
• Change in TR grade by Echocardiography

Full Information

First Posted
March 2, 2023
Last Updated
March 14, 2023
Sponsor
Mitralix
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1. Study Identification

Unique Protocol Identification Number
NCT05767645
Brief Title
Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
Acronym
TRIBUTE
Official Title
Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitralix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Valve Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mistral device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mistral Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
• Safety
Description
Incidence of Major Device Related Adverse Events (MDRAE).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety - Incidence of Major Device Related Adverse Events
Description
Incidence of Major Device Related Adverse Events (MDRAE).
Time Frame
1, 6, 12, and 24 months
Title
Safety - Incidence of device or procedure related serious adverse events
Description
Incidence of device or procedure related serious adverse events
Time Frame
30 days
Title
Effectiveness TR
Description
• Change in TR grade by Echocardiography
Time Frame
1, 6, 12, and 24 months over baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Subject with active endocarditis. Subject has echocardiographic evidence of intra-cardiac mass, thrombus, vegetation or soft-mobile deposits. Subject has hemodynamic instability requiring inotropic or mechanical support. Subject has a known hypersensitivity or contraindication to anticoagulant and antiplatelet medication. Subject is on chronic dialysis. Bleeding disorders or hypercoagulable state. In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding. Subject has a known allergy to Nitinol alloys, 316L\304 stainless steel. Pregnant or lactating women. Patients being dependent upon the sponsor or upon the investigator or upon the investigational site. According to investigator on site the patient is suffering from a severe end stage disease (e.g. malignancy, severe pulmonary disease, liver disease, renal failure). Contraindication for TEE (transesophageal echocardiography) including trans-gastric views. Life expectancy of less than 1 year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Yaron
Phone
+972542330022
Email
dana@mitralix.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ira Yaron
Phone
+972544402636
Email
ira@mitralix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronen Rubinshtein
Organizational Affiliation
Wolfson
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfson Medical Center
City
H̱olon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Israelson
Phone
+97235028699
Email
MaryI@wmc.gov.il
First Name & Middle Initial & Last Name & Degree
Ronen Rubinshtein

12. IPD Sharing Statement

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Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study

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