Brief Summary
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Brief Title
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
612-469-1749
Central Contact Email
rs.tmvrpivotaltrial@medtronic.com
Completion Date
Completion Date Type
Estimated
Conditions
Mitral Valve Regurgitation
Eligibility Criteria
Inclusion Criteria:
* Moderate to severe or severe symptomatic mitral regurgitation
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
Exclusion Criteria:
* prior transcatheter mitral valve procedure with device currently implanted
* anatomic contraindications
* prohibitive mitral annular calcification
* left ventricular ejection fraction \<25%
* need for emergent or urgent surgery
* hemodynamic instability
* Moderate to severe or severe symptomatic mitral regurgitation
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
Exclusion Criteria:
* prior transcatheter mitral valve procedure with device currently implanted
* anatomic contraindications
* prohibitive mitral annular calcification
* left ventricular ejection fraction \<25%
* need for emergent or urgent surgery
* hemodynamic instability
Inclusion Criteria
Inclusion Criteria:
* Moderate to severe or severe symptomatic mitral regurgitation
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
* Moderate to severe or severe symptomatic mitral regurgitation
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
Gender
All
Gender Based
false
Keywords
Heart disease
valve disease
heart valve disease
mitral regurgitation
cardiovascular disease
mitral insufficiency
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03242642
Org Class
Industry
Org Full Name
Medtronic Cardiovascular
Org Study Id
MDT17022TMV001
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Primary Outcomes
Outcome Description
Composite of all-cause mortality or heart failure hospitalization
Outcome Measure
Primary Cohort
Outcome Time Frame
1 year
Outcome Description
All-cause mortality
Outcome Measure
MAC Cohort
Outcome Time Frame
1 year
Secondary Outcomes
Outcome Description
Composite
Outcome Time Frame
30 days or hospital discharge (whichever is later)
Outcome Measure
All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding
Outcome Description
measured by echocardiography
Outcome Time Frame
6 months
Outcome Measure
Degree of mitral regurgitation
Outcome Description
measured by KCCQ
Outcome Time Frame
3 months (KCCQ)
Outcome Measure
Quality of Life Improvement
Outcome Description
change in NYHA Class
Outcome Time Frame
30 days
Outcome Measure
Change in New York Heart Association Class
Outcome Description
measured by echocardiography
Outcome Time Frame
1 year
Outcome Measure
Echocardiographic assessments of degree mitral valve regurgitation
Outcome Description
cardiovascular hospitalizations
Outcome Time Frame
1 year
Outcome Measure
Cardiovascular hospitalizations
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mohamed Azeem Latib
Investigator Email
mlatib@montefiore.org
Investigator Phone
646-773-2076