Testing Medtronic Intrepid Transcatheter Mitral for mitral valve regurgitation
Official title: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
- 2 groups
- Sites in New Westminster, Vancouver and 2 more cities
- Recruiting
Interventions
- Medical device
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
mitral valve replacement
- Medical device
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
Canadian Sites (6)
6 of 6 recruiting
- Recruiting
Royal Columbian Hospital
New Westminster, British Columbia
- Recruiting
Saint Paul's Hospital
Vancouver, British Columbia
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
- Recruiting
Saint Michael's Hospital
Toronto, Ontario
- Recruiting
Montreal Heart Insitute
Montreal, Quebec
- Recruiting
Glen Royal Victoria Hospital
Montreal, Quebec
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Moderate to severe or severe symptomatic mitral regurgitation
- +Local siteTrial siteA hospital or clinic where a study is actually run.Read more → 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
- −prior transcatheter mitral valve procedure with device currently implanted
- −anatomic contraindications
- −prohibitive mitral annular calcification
- −left ventricular ejection fraction \<25%
- −hemodynamic instability
- −need for emergent or urgent surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B receive Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR).
Registry label: A: Primary Cohort- TMVR · B: Mitral Annular Calcification -TMVR
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,056 people.
The study is currently expected to finish around September 2036.
The main measurement is taken over: 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Primary CohortCohortA group of participants sharing a characteristic, followed together.Read more → — measured over 1 year.
MAC Cohort — measured over 1 year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03242642 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)Device
mitral valve replacement
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)Device
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 year.
The study as a whole is currently expected to finish around 2036-09-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,056 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 15 locations, including: New Westminster, British Columbia, Canada; Vancouver, British Columbia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Ann Arbor, Michigan, United States; Detroit, Michigan, United States, and 9 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Other Sites (16)
University of Michigan Health System
Ann Arbor, Michigan, United States
Henry Ford Saint John Hospital
Detroit, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, United States
Providence St Patrick
Missoula, Montana, United States
Northwell Health North Shore University Hospital
Manhasset, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
NYU Langone Medical Center
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
New York-Presbyterian Hospital Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Saint Francis Hospital
Roslyn, New York, United States
The Swedish Medical Center Cherry Hill
Seattle, Washington, United States
University of Washington (UW) Medical Center
Seattle, Washington, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.