MATTERS II - Mistral Percutaneous Tricuspid Valve Repair FIM Study

NCT04073979 | Completed

• 1 other identifier: CL-605
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

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)

• 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

• 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 (25)

• Safety: Rate of all SAEs

  At 3 months post procedure

• Safety: Rate of all SAEs

  At 6 months post procedure

• Safety: Rate of all SAEs

  At 12 months post procedure

• Safety: Rate of all SAEs

  At 24 months post procedure

• Effectiveness TR

  Until hospital discharge - up to 5 days post procedure day

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
• Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;
• 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.
• Subjects with Aortic and/or Mitral valve severe stenosis and/or severe regurgitation.
• Subjects with severe, uncontrolled hypertension.
• Subjects with previous tricuspid repair or replacement.
• Subjects, which need to undergo an emergency surgery.
• Subjects participating in another clinical investigation.
• Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 90 days.
• Subject has a history of a myocardial infarction (MI) in the past 90 days.
• Subject has had a percutaneous interventional, including coronary intervention (PCI), within the last 90 days before 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.

Sponsors & Collaborators

• Mitralix: lead

Study Sites (4)

Cardiovascular Center (CVC)

Frankfurt, Germany

Location

Marienkrankenhaus

Hamburg, 22087, Germany

Location

Medizinisches Versorgungszentrum Albertinen (MVZ)

Hamburg, 22527, Germany

Location

LMU [Ludwig-Maximilians-Universität München]

Munich, 80539, Germany

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: August 25, 2019
• First Posted: August 29, 2019
• Study Start: April 2, 2019
• Primary Completion: January 31, 2021
• Study Completion: December 31, 2022
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

DE (4)