MATTERS Study - Mistral Percutaneous Tricuspid Valve Repair FIM Study

NCT04071652 | Completed

• 1 other identifier: CL-475
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

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 (3)

• Safety: Acute safety. Rate of device related SAE

  including device related mortality, stroke, MI, cardiac tamponade, surgery for failed percutaneous repair and non-elective cardiovascular surgery to treat an adverse event

  Until hospital discharge - up to 5 days post procedure day

• Safety: Acute safety. Rate of device related SAE

  including device related mortality, stroke, MI, cardiac tamponade, surgery for failed percutaneous repair and non-elective cardiovascular surgery to treat an adverse event

  At 30 days post procedure

• Performance: Mistral Implantation rate of technical success

  defined as successful device implantation with grasped chords from at least two leaflets

  Procedure

Secondary Outcomes (26)

• Safety: Rate of device related SAE

  at 3 months post procedure

• Safety: Rate of device related SAE

  at 6 months post procedure

• Safety: Rate of device related SAE

  at 12 months post procedure

• Safety: Rate of device related SAE

  at 24 months post procedure

• Effectiveness: TR Grade reduction

  post procedure (1 hour after implant device has been implanted)

Study Arms (1)

Mistral

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 implantation

Interventions

Mistral implantation DEVICE

Mistral implant is implanted in the Tricuspid valve

Mistral

Eligibility Criteria

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

You may qualify if:

• Subject has given signed study Informed Consent for participation prior to procedure.
• Subject is ≥ 18 years of age or legal age in host country
• Subject is willing and able to comply with all required follow-up evaluations
• Genders eligible for the study: Both genders
• Subject has TR of grade 3+ or more
• Subject has left ventricular ejection fraction (LVEF) \>20 %
• Subject is of functional class 2 or more (NYHA)
• The subject is high risk to undergo TV surgery as assessed and consented by a cardiac surgeon and an interventional cardiologist at the site (center heart team), and according to ESC/EACTS guidelines on the management of valvular heart disease.
• Patients with Jugular and/or Femoral veins enabling catheterization with 12Fr catheters
• Life expectancy ≥ 1 year

You may not qualify if:

• Tricuspid Stenosis \>mild
• Tricuspid Subvalvular calcification or calcification of the chordae.
• Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months.
• Subject has a history of a myocardial infarction (MI) in the past 3 months
• Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 7 days of the index procedure
• Subject has a history of, or has active endocarditis
• Subject has echocardiographic evidence of intra-cardiac mass, thrombus, vegetation or soft-mobile deposits
• Subject is in acute pulmonary edema.
• Subject has hemodynamic instability requiring inotropic or mechanical support.
• Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication
• Subject has renal insufficiency as evidenced by a serum Creatinine \> 3.0mg/dL.
• Subject has ongoing infection or sepsis
• Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy)
• Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months prior to the index procedure
• Subject requires emergency surgery for any reason

Sponsors & Collaborators

• Mitralix: lead

Study Sites (3)

Haddassah

Jerusalem, Kiryat Hadassah, 91120, Israel

Location

The Chain Sheba Medical Center at Tel HaShomer

Ramat Gan, 52621, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

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: April 13, 2017
• First Posted: August 28, 2019
• Study Start: August 8, 2017
• Primary Completion: October 1, 2020
• Study Completion: February 28, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

IL (3)