Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study

NCT05767645 | Unknown

• 1 other identifier: CL-1048
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Tricuspid Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

• • Safety

  Incidence of Major Device Related Adverse Events (MDRAE).

  6 months

Secondary Outcomes (3)

• Safety - Incidence of Major Device Related Adverse Events

  1, 6, 12, and 24 months

• Safety - Incidence of device or procedure related serious adverse events

  30 days

• Effectiveness TR

  1, 6, 12, and 24 months over baseline

Study Arms (1)

Mistral device

EXPERIMENTAL

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.

Device: Mistral Procedure

Interventions

Mistral Procedure DEVICE

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.

Mistral device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mitralix: lead

Study Sites (1)

Wolfson Medical Center

Holon, Israel

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ronen Rubinshtein

  Wolfson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Yaron

CONTACT

+972542330022; dana@mitralix.com

Ira Yaron

CONTACT

+972544402636; ira@mitralix.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: June 21, 2021
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2025
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

IL (1)