An interventional study of Mitral Valve Replacement (MVR) with Sapien3 in Mitral Annular Calcification, sponsored by Baylor Research Institute. Completed at 6 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Baylor Research Institute · Not applicable, Interventional, and Treatment
Among 117 studies in Mitral Valve Insufficiency with a site in United States — 34 open to participants now, 54 under way, none of them phase 3. Mitral Valve Insufficiency · United States.
Among the 117 studies in Mitral Valve Insufficiency with a site in United States, this one is the 60th largest by enrollment of the 80 interventional ones that give a count, is one of 6 that started in 2016, is one of 63 with no phase, and was the 39th registered.
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
Browse Mitral Valve Insufficiency studies →34 of the 117 studies in Mitral Valve Insufficiency with a site in United States are open now. Recruiting first, the newest first:
Capstan Medical · Sites in United States
Polares Medical SA · Sites in United States
InnovHeart · Sites in United States
Nyra Medical, Inc. · Sites in United States
Columbia University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 122 Mitral Valve Insufficiency studies recruiting now, 101 (83%) set no upper age limit and 6 (5%) stop at 75 or younger; 13 take children under 18; 1 take healthy volunteers.
This study: 22 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
117 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 8 · Phase 3 4 · Phase 4 4
First in 1992; this study’s year is marked. 6 started in 2016.
This study's enrollment of 25 is below the median of 68 across 279 interventional studies indexed under Mitral Valve Insufficiency.
Median enrollment 60 across the 80 interventional studies, 200 across the 37 observational. Of the 50 that completed or were terminated, 25 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
61 of 117 have an industry lead sponsor. The 10 most frequent:
Baylor Research Institute is the lead sponsor of 223 studies on the registry; 48 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Baylor Research Institute has 1 study filed under Mitral Valve Insufficiency — fewer than ten, so there is no comparison to draw.
13 of the studies in Mitral Valve Insufficiency with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04408430Mayra GuerreroThe MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves). | 2026-12 |
| NCT07655505Intuitive SurgicalUse of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair | 2026-12-31 |
| NCT05061004Abbott Medical DevicesCephea Early Feasibility Study | 2026-12-31 |
| NCT03142152Cardiac Dimensions, Inc.The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR | 2026-12-31 |
| NCT06738615Atlantic Health SystemAssessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity | 2027-01-02 |
Among the 117 studies in Mitral Valve Insufficiency with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed inoperable due to the extent of calcification.
Technical Success:
Alive, with
Device Success:
Alive and stroke free, with
Intended performance of the device:
Procedural Success:
Device success, and
6.2 Secondary objective(s)
Device Success (at 6 months and 1 year)
Device Success:
Alive and stroke free, with
Intended performance of the device:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
subjects with surgical MVR with Sapien3
Device: Mitral Valve Replacement (MVR) with Sapien3
subjects with surgical MVR with Sapien3
Also known as: MVR
Procedural Success
Procedural Success is defined as: 1. Device success, and 2. No device or procedure related serious adverse events (SAEs) (Life threatening bleed; major vascular or cardiac structural complications requiring unplanned reintervention or surgery; stage 2 or 3 acute kidney injury (AKI) (includes new dialysis); myocardial infarction (MI) or need for percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG); severe heart failure (HF) or hypotension requiring intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support; prolonged intubation ( \> 48 hours)
Time frame: 30 days
Technical Success
Technical Success is defined as: 1. Alive, with 2. Successful access, delivery and retrieval of the device delivery system, and 3. Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and 4. No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
Time frame: Procedure Stop Time
Device Success
Device Success is defined as: 1. Alive and stroke free, with 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/operating room (OR)), and 4. Intended performance of the device: 1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and 2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = mitral valve area (MVA) \< 1.5cm2 and mitral valve (MV) gradient \> 5mmHg, Insufficiency = mitral regurgitation (MR) \>1+), and 3. Absence of para-device complications (e.g., paravalvular leak (PVL) \> mild, need for a permanent pacemaker (PPM), erosion, Annular rupture or aortic valve (AV) Groove disruption, left ventricular outflow tract (LVOT) gradient increase \> 10mmHg)
Time frame: 30 days
Device Success
Device Success is defined as: 1. Alive and stroke free, with 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/operating room (OR)), and 4. Intended performance of the device: 1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and 2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA \< 1.5cm2 and MV gradient \> 5mmHg, Insufficiency = MR \>1+), and 3. Absence of para-device complications (e.g., PVL \> mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase \> 10mmHg)
Time frame: 6 months
Device Success
Device Success is defined as: 1. Alive and stroke free, with 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/OR), and 4. Intended performance of the device: 1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and 2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA \< 1.5cm2 and MV gradient \> 5mmHg, Insufficiency = MR \>1+), and 3. Absence of para-device complications (e.g., PVL \> mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase \> 10mmHg)
Time frame: 1 year
Subject Success
Subject Success is defined as: All of the following must be present: I. Device success (either optimal or acceptable), and II. Patient returned to the pre-procedural setting: and III. No rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, heart failure); and IV. Improvement from baseline in symptoms (e.g., NYHA improvement by \> or = 1 functional class); and V. Improvement from baseline in functional status (e.g., 6-min walk test improvement by \> or = 50 m); and VI. Improvement from baseline in quality-of-life (e.g., Kansas City Cardiomyopathy Questionnaire improvement by \> or = 10)
Time frame: 1 year
This was a prospective, open-label, multicenter study which identified participants from 8 participating institutions, with 6 different study sites enrolling participants into the trial. First participant enrollment took place on 11/04/2016 with the final participant enrolled on 08/05/2022. All participants were followed for 12 months with the final participant visit taking place on 11/29/2023.
| Milestone | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Started | 25 |
| Discharge visit | 18 |
| 30 day visit | 18 |
| 6 month visit | 16 |
| Completed | 15 |
| Not completed | 10 |
| Withdrew: Death | 9 |
| Withdrew: Withdrawal by subject | 1 |
Procedural Success is defined as: 1. Device success, and 2. No device or procedure related serious adverse events (SAEs) (Life threatening bleed; major vascular or cardiac structural complications requiring unplanned reintervention or surgery; stage 2 or 3 acute kidney injury (AKI) (includes new dialysis); myocardial infarction (MI) or need for percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG); severe heart failure (HF) or hypotension requiring intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support; prolonged intubation ( \> 48 hours)
| Participants | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Met Outcome Measure | 16 |
| Did Not Meet Outcome Measure | 9 |
Technical Success is defined as: 1. Alive, with 2. Successful access, delivery and retrieval of the device delivery system, and 3. Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and 4. No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
| Participants | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Met Outcome Measure | 21 |
| Did Not Meet Outcome Measure | 4 |
Device Success is defined as: 1. Alive and stroke free, with 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/operating room (OR)), and 4. Intended performance of the device: 1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and 2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = mitral valve area (MVA) \< 1.5cm2 and mitral valve (MV) gradient \> 5mmHg, Insufficiency = mitral regurgitation (MR) \>1+), and 3. Absence of para-device complications (e.g., paravalvular leak (PVL) \> mild, need for a permanent pacemaker (PPM), erosion, Annular rupture or aortic valve (AV) Groove disruption, left ventricular outflow tract (LVOT) gradient increase \> 10mmHg)
| Participants | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Known met Outcome Measure | 0 |
| Unknown | 12 |
| Did not meet Outcome Measure | 13 |
Device Success is defined as: 1. Alive and stroke free, with 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/operating room (OR)), and 4. Intended performance of the device: 1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and 2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA \< 1.5cm2 and MV gradient \> 5mmHg, Insufficiency = MR \>1+), and 3. Absence of para-device complications (e.g., PVL \> mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase \> 10mmHg)
| Participants | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Known Met Outcome Measure | 0 |
| Unknown | 11 |
| Known Did Not Meet Outcome Measure | 14 |
Device Success is defined as: 1. Alive and stroke free, with 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/OR), and 4. Intended performance of the device: 1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and 2. Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA \< 1.5cm2 and MV gradient \> 5mmHg, Insufficiency = MR \>1+), and 3. Absence of para-device complications (e.g., PVL \> mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase \> 10mmHg)
| Participants | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Known Met Outcome Measure | 2 |
| Unknown | 10 |
| Known Did Not Meet Outcome Measure | 13 |
Subject Success is defined as: All of the following must be present: I. Device success (either optimal or acceptable), and II. Patient returned to the pre-procedural setting: and III. No rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, heart failure); and IV. Improvement from baseline in symptoms (e.g., NYHA improvement by \> or = 1 functional class); and V. Improvement from baseline in functional status (e.g., 6-min walk test improvement by \> or = 50 m); and VI. Improvement from baseline in quality-of-life (e.g., Kansas City Cardiomyopathy Questionnaire improvement by \> or = 10)
| Participants | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Known Met Outcome Measure | 0 |
| Unknown | 10 |
| Known Did Not Meet Outcome Measure | 15 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mitral Valve Replacement With SAPEIN3 | 9/25 (36%) | 20/25 (80%) | 24/25 (96%) |
| Event | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Arrhythmia and/or Conduction System InjuryCardiac disorders | 5/25 |
| Pleural EffusionCardiac disorders | 4/25 |
| BleedingSurgical and medical procedures | 3/25 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 3/25 |
| Renal Failure or InsufficienyRenal and urinary disorders | 3/25 |
| Respirator FailureRespiratory, thoracic and mediastinal disorders | 3/25 |
| Atrioventricular (A-V) Groove DisruptionCardiac disorders | 2/25 |
| Heart FailureCardiac disorders | 2/25 |
| HematomaBlood and lymphatic system disorders | 2/25 |
| Paravalvular LeakCardiac disorders | 2/25 |
| Event | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| AnemiaBlood and lymphatic system disorders | 8/25 |
| Arrhythmia and/or Conduction System InjuryCardiac disorders | 6/25 |
| BleedingSurgical and medical procedures | 4/25 |
| Renal Failure or InsufficiencyRenal and urinary disorders | 4/25 |
| Plural EffusionCardiac disorders | 3/25 |
| Plasma Free Hemoglobin and Haptoglobin ElevatedBlood and lymphatic system disorders | 3/25 |
| Heart FailureCardiac disorders | 2/25 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/25 |
| Lactate Dehydrogenase (LDH) ElevatedBlood and lymphatic system disorders | 2/25 |
| Pulmonary EdemaRespiratory, thoracic and mediastinal disorders | 2/25 |
| Age, Continuous(years) | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Mean | 75.6 ± 7.1 |
| Sex: Female, Male(Participants) | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Female | 20 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | Mitral Valve Replacement With SAPEIN3 |
|---|
| Body mass index (BMI)(kg/m^2) | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Mean | 29.63 ± 5.7 |
| New York Heart Association (NYHA) Classification(units on a scale) | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Mean | 2.84 ± 0.69 |
| Society of Thoracic Surgeons (STS) Risk of Mortality Mitral Valve Repair(Percentage) | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Mean | 4.00 ± 2.57 |
| Society of Thoracic Surgeons (STS) Risk of Mortality Mitral Valve Replacement(Percentage) | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Mean | 6.13 ± 2.84 |
| Forced expiratory volume in 1 second (FEV1%)(Percentage) | Mitral Valve Replacement With SAPEIN3 |
|---|---|
| Mean | 63.47 ± 26.93 |
10 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is currently no plan to share individual participant data
Ran from Nov 2016 to primary completion in Jan 2023, 73 months.
Results were first posted in Feb 2025, 2 years 1 month after primary completion.
Of 143 interventional studies with no phase under Mitral Valve Insufficiency, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 108. This study's 73 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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