NCT02948231

Brief Summary

The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Mitral Regurgitation. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

June 25, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

April 7, 2022

Status Verified

February 1, 2022

Enrollment Period

4.5 years

First QC Date

June 21, 2016

Last Update Submit

April 6, 2022

Conditions

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (21)

  • 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

  • Effectiveness: MR Grade reduction.

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

  • Effectiveness: MR Grade reduction.

    Until hospital discharge - up to 5 days post procedure day

  • +16 more secondary outcomes

Study Arms (1)

Mistral

EXPERIMENTAL
Device: Mistral implantation

Interventions

Mistral implantationDEVICE

Mistral Implant is implanted in the Mitral valve

Mistral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is willing and able to comply with all required follow-up evaluations
  • Genders eligible for the study: Both genders
  • Subject has functional MR of grade 3+ or more
  • Subject has left ventricular ejection fraction (LVEF) \>20 % and \< 40%.
  • No contraindications to trans-septal puncture
  • Subject is of functional class 3 or more (NYHA)
  • The subject is high risk to undergo MV surgery.
  • Subject is excluded from other standard of care procedures as determined by center heart team.
  • Patients with femoral veins enabling catheterization with 12Fr catheters
  • Life expectancy ≥ 1 year

You may not qualify if:

  • Mitral Stenosis ≥ moderate
  • Aortic Stenosis/Insufficiency \> moderate
  • Subvalvular calcification or calcification of the chordae.
  • Subject has a prosthesis valve in the mitral position
  • Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration
  • 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 refuses blood transfusion or surgical valve replacement.
  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZNA Middelheim

Antwerp, 2020, Belgium

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular 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

June 21, 2016

First Posted

October 28, 2016

Study Start

June 25, 2016

Primary Completion

January 1, 2021

Study Completion

February 1, 2022

Last Updated

April 7, 2022

Record last verified: 2022-02

Locations

BE(1)