Testing AltaValve System. for mitral regurgitation
Official title: ATLAS (AltaValve) Pivotal Trial
ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) Pivotal Trial
- 2 groups
- Sites in Vancouver, Toronto and 1 more city
- Recruiting
Interventions
- Medical device
AltaValve System.
Transcatheter Mitral Valve Replacement.
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
St. Paul's Hospital
Vancouver, British Colombia
- Recruiting
St. Michael's Unity Health Toronto
Toronto, Ontario
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec
Eligibility Criteria
See who this study is looking for30 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age ≥ 18 years.
- +Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
- +Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
- +Known hypersensitivity to contrast media that cannot be adequately medicated.
- +Symptomatic New York Heart Association (NYHA) class II-IV.
- +Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → (Abbreviated List):
- +Inability to understand the trial or a history of non-compliance with medical advice.
- +Inability to provide signed Informed Consent FormInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (ICF).
- +History of any cognitive or mental health status that would interfere with participation in the trial.
- +Currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpointsEndpointThe specific thing a study measures to answer its question.Read more → (e.g., limit use of trial-required medication, etc.)).
- +Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
- +Concurrent medical condition with a life expectancy of less than 12 months.
- +Transcatheter aortic repair or replacement within 90 days prior to the baselineBaselineYour starting measurements, taken before treatment begins.Read more → required tests.
- +Percutaneous coronary intervention (PCI) within 30 days prior to the index procedure.
- +Female subjects who are pregnant or planning to become pregnant within the trial period.
- +Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local siteTrial siteA hospital or clinic where a study is actually run.Read more → Heart Team.
Exclusion
- −Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
- −Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
- −Known hypersensitivity to contrast media that cannot be adequately medicated.
- −(Abbreviated List):
- −Inability to understand the trial or a history of non-compliance with medical advice.
- −Inability to provide signed Informed Consent FormInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (ICF).
- −History of any cognitive or mental health status that would interfere with participation in the trial.
- −Currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpointsEndpointThe specific thing a study measures to answer its question.Read more → (e.g., limit use of trial-required medication, etc.)).
- −Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
- −Concurrent medical condition with a life expectancy of less than 12 months.
- −Transcatheter aortic repair or replacement within 90 days prior to the baselineBaselineYour starting measurements, taken before treatment begins.Read more → required tests.
- −Percutaneous coronary intervention (PCI) within 30 days prior to the index procedure.
- −Female subjects who are pregnant or planning to become pregnant within the trial period.
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 AltaValve System..
Registry label: A: Primary Cohort · B: Mitral Annular Calcification Cohort (MAC)
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 450 people.
The study is currently expected to finish around September 2031.
The main measurement is taken over: 12 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Composite of all-cause mortality or heart failure hospitalization — measured over 12 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06465745 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 AltaValve System.Device
Transcatheter 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: 12 months..
The study as a whole is currently expected to finish around 2031-09.
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 450 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 11 locations, including: Vancouver, British Colombia, Canada; Toronto, Ontario, Canada; Québec, Quebec, Canada; Ann Arbor, Michigan, United States; Detroit, Michigan, United States; Royal Oak, Michigan, United States, and 5 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
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
Other Sites (8)
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Washington
Seattle, 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.