Mitral RegurgitationSAPIEN M3 EFSNCT03230747
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
A study testing Edwards SAPIEN M3 System in people with Mitral Regurgitation and Mitral Disease, run by Edwards Lifesciences at 9 sites in 2 countries.
Trial summary
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Disease
- What is being tested?
- Edwards SAPIEN M3 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 14 Sep 2017to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- MR ≥ 3+
- NYHA functional class ≥ II
- High risk of cardiovascular surgery
- Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Who cannot join
- Mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- Significant risk of LVOT obstruction
- Severe right ventricular dysfunction
- LV Ejection Fraction <30%
- Patient is inoperable
Show all 26Show fewer
- Prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment
- Need for aortic, tricuspid or pulmonic valve replacement
- Presence of mechanical aortic valve prosthesis
- History of cardiac transplantation
- History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism
- Clinically significant untreated coronary artery disease requiring revascularization
- Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days.
- Stroke or transient ischemic attack within 90 days of the procedure
- Myocardial infarction within 30 days of the procedure
- Active bacterial endocarditis within 180 days of the procedure
- Inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy
- Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
- Hospitalization for CHF or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days.
- Irreversible, severe pulmonary hypertension
- Patients with renal insufficiency or receiving renal replacement therapy
- Liver disease or significantly abnormal liver function test results
- Refusal of blood products
- Female who is pregnant or lactating
- Estimated life expectancy < 12 months
- Participating in another investigational drug or device study
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Emory University
Atlanta, Georgia, 30308
Henry Ford Hospital
Detroit, Michigan, 48202
Evanston/ Northshore University
Evanston, Illinois, 60201
Cedars-Sinai Medical Center Heart Institute
Los Angeles, California, 90048
Intermountain Medical Center
Murray, Utah, 84107
Sentara Cardiovascular Research Institution
Norfolk, Virginia, 23507
Mayo Clinic
Rochester, Minnesota, 55905
California Pacific Medical Center
San Francisco, California, 94109
About this study
Official title: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
Read the detailed description
Prospective, single-arm, multicenter early feasibility study
- Conditions
- Mitral Regurgitation, Mitral Disease
- Being tested
- Edwards SAPIEN M3 System
- Keywords
- Transcatheter Mitral Valve Replacement, SAPIEN M3
- Medical subject headings
- Mitral Valve Insufficiency, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards SAPIEN M3 SystemDevice
SAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock
| Study group | Role | What they receive |
|---|---|---|
| TMVR | Experimental | Subjects will undergo transcatheter mitral valve replacement Receives: Device: Edwards SAPIEN M3 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Defined as meeting all the following:
- Alive
- Successful access, delivery and retrieval of the delivery systems
- Deployment of the devices in the intended position
- Freedom from emergency surgery or reintervention related to the device or access procedure
Measured: At the end of the procedure
Secondary outcomes (1)
Reduction in mitral regurgitation (MR)
Reduction in MR to 0 or 1+
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start14 Sep 2017
- Primary completion16 Jun 2021
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230747
- Sponsor's protocol ID
- 2017-03
- Acronym
- SAPIEN M3 EFS
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2017
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT03230747
- Acronym / sponsor ID
- SAPIEN M3 EFS / 2017-03
- Conditions
- Mitral Regurgitation, Mitral Disease
- Keywords
- Transcatheter Mitral Valve Replacement, SAPIEN M3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
Detailed description
Prospective, single-arm, multicenter early feasibility study
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMVR | Experimental | Device: Edwards SAPIEN M3 SystemSubjects will undergo transcatheter mitral valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- MR ≥ 3+
- NYHA functional class ≥ II
- High risk of cardiovascular surgery
- Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure
Key exclusion criteria (26 listed)
- Mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- Significant risk of LVOT obstruction
- Severe right ventricular dysfunction
- LV Ejection Fraction <30%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edwards SAPIEN M3 SystemSAPIEN M3 System includes the SAPIEN M3 valve and the SAPIEN M3 dock | Device | TMVR |
Primary outcome
Technical Success
Time frame: At the end of the procedure
Defined as meeting all the following: * Alive * Successful access, delivery and retrieval of the delivery systems * Deployment of the devices in the intended position * Freedom from emergency surgery or reintervention related to the device or access procedure
1 secondary outcome
Reduction in mitral regurgitation (MR)
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
Edge-to-edge Mitral Valve Repair in ATTR-CM
Mitral Regurgitation, ATTR-Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards SAPIEN M3 System in people with Mitral Regurgitation and Mitral Disease, run by Edwards Lifesciences at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: At the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.