Mitral Valve RegurgitationNCT02321514
Expanded Clinical Study of the Tendyne Mitral Valve System
A study testing Tendyne Mitral Valve System in people with Mitral Valve Regurgitation, run by Abbott Medical Devices at 40 sites in 10 countries.
Trial summary
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Tendyne Mitral Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 40 sitesin 10 countries
- Study dates
- Nov 2014to Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Severe mitral regurgitation of primary or secondary etiology according to MVARC (Mitral Valve Academic Research Consortium) 2015 defined as:
- For Degenerative MR: EROA ≥ 40 mm^2 or regurgitant volume ≥ 60ml
- For Secondary MR: EROA ≥ 20 mm^2 or regurgitant volume ≥ 30ml
- New York Heart Association (NYHA) functional Class ≥ II while on guideline directed medical therapy (GMDT), including device therapy (CRT) if indicated.
- Heart team determines patient is not a suitable candidate for traditional surgical treatment according to valid guidelines.
- Age 18 years or older.
Who cannot join
- Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
- Left Ventricle (LV) or Left Atrium (LA) thrombus.
- Patient has a chest condition that prevents transapical access.
- Left ventricular ejection fraction (LVEF) less than 30% by echocardiogram.
- Left Ventricular End Diastolic Diameter (LVEDD) > 7.0 cm.
- Prior surgical or interventional treatment of mitral or aortic valves (e.g. valve repair or replacement, MitraClip, edge to edge repair, aortic balloon valvuloplasty, etc.).
Show all 28Show fewer
- Any planned surgery or interventional procedure within the period of 30 days prior to 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.
- Cardiac resynchronization therapy device or implantable pulse generator implanted within three months of planned implant procedure.
- Myocardial Infarction (MI) within 30 days of the planned implant procedure.
- Symptomatic, unresolved multi-vessel coronary artery disease (CAD) or unprotected left main coronary artery disease requiring stenting or Coronary Artery Bypass Grafting (CABG).
- Cerebrovascular accident (CVA) within six months of planned implant procedure.
- Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
- Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
- Severe tricuspid regurgitation, tricuspid valve disease requiring surgery or severe right ventricular dysfunction.
- Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
- Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated.
- History of endocarditis within six months of planned implant procedure.
- Active systemic infection requiring antibiotic therapy.
- Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation therapy) which cannot be adequately managed medically or hypersensitivity to nickel or titanium.
- Patient is undergoing hemodialysis due to chronic renal failure.
- Patient has pulmonary arterial hypertension (fixed PAS >70mmHg).
- Patient has COPD and is on home oxygen.
- Patient refuses blood transfusions.
- Pregnant, lactating, or planning pregnancy within next 12 months.
- Participating or planning participation in an investigational drug or another device study.
- Patient or legal guardian unable or unwilling to give informed consent.
- Patient unable or unwilling to comply with study required testing and follow-up visits.
- Patients with non-cardiac co-morbidities that are likely to result in a life expectancy of less than one year.
Trial locations and contacts
40 sites in 10 countries.
40 sites in 10 countries
United States13 sites
Emory University Hospital
Atlanta, Georgia, 30322
Morton Plan Mease Health Care
Clearwater, Florida, 33756
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor Heart & Vascular Center
Dallas, Texas, 75226
Delray Medical Center
Delray Beach, Florida, 33484
Henry Ford Hospital
Detroit, Michigan, 48202
Northshore University Health System
Evanston, Illinois, 60201
Pinnacle Health - Harrisburg Hospital
Harrisburg, Pennsylvania, 17104
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
West Virginia University
Morgantown, West Virginia, 26506
St. Francis Hospital
Roslyn, New York, 11576
Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260
MedStar Washington Hospital
Washington D.C., District of Columbia, 20010
Germany9 sites
Deutsche Herzzentrum Berlin
Berlin, 13353
Universitätsklinikum Bonn
Bonn, 53105
University Hospital Dresden
Dresden
Universitätsklinikum Frankfurt
Frankfurt, 60590
University Heart Center Hamburg
Hamburg, 20251
Leipzig Heart Center
Leipzig, 04289
University Medical Center Mainz
Mainz, 55131
Ludwig-Maximilians-Universität München (LMU)
Munich
University of Rostock
Rostock, 18057
France5 sites
Bordeaux University Hospital
Bordeaux
CHRU de Lille
Lille, 59000
Lyon University Hospital
Lyon
Rennes University Hospital
Rennes
Clinique Pasteur
Toulouse, 31300
Italy5 sites
Ospedale Ferrarotta - Catania
Catania, 95124
San Raffaele
Milan, 20132
Pisa University
Pisa
Humanitas Research Hospital
Rozzano, 56-20089
San Donato
San Donato Milanese, 20097
Australia3 sites
Flinders Medical Center
Bedford Park, 5042
Prince Charles Hospital
Chermside
St. Vincent's Hospital
Sydney
About this study
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Tendyne Mitral Valve System
- Keywords
- ABT-CIP-10337, Tendyne Bioprosthetic Mitral Valve System
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendyne Mitral Valve SystemDevice
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system
| Study group | Role | What they receive |
|---|---|---|
| Tendyne Mitral Valve System | Experimental | Patients will undergo transcatheter mitral valve replacement Receives: Device: Tendyne Mitral Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs)
Device success and freedom from the following device- or procedure-related serious adverse events (SAEs) at 30 days post the index procedure, will be classified by the Clinical Events Committee (CEC):
- Cardiovascular death
- Reintervention caused by valve-related dysfunction
- Disabling stroke
- Myocardial infarction (MI)
- Life-threatening bleeding (BARC Type 2, 3, and 5)
- Major Vascular Complications
- Renal failure requiring dialysis
- Other device-related SAEs
- Other procedure-related SAEs
Measured: 30 days post-index procedure
Performance Endpoint: Number of Participants With MR Grade ≤ 2
Proportion of subjects with mitral regurgitation (MR) grade ≤ 2, per echocardiography core laboratory will be assessed.
MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Measured: 30 days post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2020
- Study completionApr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321514
- Sponsor's protocol ID
- CS-03
- Status last verified
- Jul 2025
- First submitted
- 10 Dec 2014
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Muller DWM, Sorajja P, Duncan A, Bethea B, Dahle G, Grayburn P, Babaliaros V, Guerrero M, Thourani VH, Bedogni F, Denti P, Dumonteil N, Modine T, Jansz P, Chuang ML, Blanke P, Leipsic J, Badhwar V. 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. J Am Coll Cardiol. 2021 Nov 9;78(19):1847-1859. doi: 10.1016/j.jacc.2021.08.060.
PubMed 34736561Muller DWM, Farivar RS, Jansz P, Bae R, Walters D, Clarke A, Grayburn PA, Stoler RC, Dahle G, Rein KA, Shaw M, Scalia GM, Guerrero M, Pearson P, Kapadia S, Gillinov M, Pichard A, Corso P, Popma J, Chuang M, Blanke P, Leipsic J, Sorajja P; Tendyne Global Feasibility Trial Investigators. Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial. J Am Coll Cardiol. 2017 Jan 31;69(4):381-391. doi: 10.1016/j.jacc.2016.10.068. Epub 2016 Dec 28.
PubMed 28040318
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Clinical Study of the Tendyne Mitral Valve System
- ClinicalTrials.gov ID
- NCT02321514
- Acronym / sponsor ID
- CS-03
- Conditions
- Mitral Valve Regurgitation
- Keywords
- ABT-CIP-10337, Tendyne Bioprosthetic Mitral Valve System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Apr 2025 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Posted 2 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tendyne Mitral Valve System | Experimental | Device: Tendyne Mitral Valve SystemPatients 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)
- Severe mitral regurgitation of primary or secondary etiology according to MVARC (Mitral Valve Academic Research Consortium) 2015 defined as:
- New York Heart Association (NYHA) functional Class ≥ II while on guideline directed medical therapy (GMDT), including device therapy (CRT) if indicated.
- Heart team determines patient is not a suitable candidate for traditional surgical treatment according to valid guidelines.
- Age 18 years or older.
Key exclusion criteria (28 listed)
- Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
- Left Ventricle (LV) or Left Atrium (LA) thrombus.
- Patient has a chest condition that prevents transapical access.
- Left ventricular ejection fraction (LVEF) less than 30% by echocardiogram.
- Left Ventricular End Diastolic Diameter (LVEDD) > 7.0 cm.
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 |
|---|---|---|
| Tendyne Mitral Valve SystemPatients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system | Device | Tendyne Mitral Valve System |
Primary outcome
Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs)
Time frame: 30 days post-index procedure
Device success and freedom from the following device- or procedure-related serious adverse events (SAEs) at 30 days post the index procedure, will be classified by the Clinical Events Committee (CEC): * Cardiovascular death * Reintervention caused by valve-related dysfunction * Disabling stroke * Myocardial infarction (MI) * Life-threatening bleeding (BARC Type 2, 3, and 5) * Major Vascular Complications * Renal failure requiring dialysis * Other device-related SAEs * Other procedure-related SAEs
Performance Endpoint: Number of Participants With MR Grade ≤ 2
Time frame: 30 days post-index procedure
Proportion of subjects with mitral regurgitation (MR) grade ≤ 2, per echocardiography core laboratory will be assessed. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34736561Muller DWM, Sorajja P, Duncan A, Bethea B, Dahle G, Grayburn P, Babaliaros V, Guerrero M, Thourani VH, Bedogni F, Denti P, Dumonteil N, Modine T, Jansz P, Chuang ML, Blanke P, Leipsic J, Badhwar V. 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. J Am Coll Cardiol. 2021 Nov 9;78(19):1847-1859. doi: 10.1016/j.jacc.2021.08.060.
- Derived from this study: PubMed 28040318Muller DWM, Farivar RS, Jansz P, Bae R, Walters D, Clarke A, Grayburn PA, Stoler RC, Dahle G, Rein KA, Shaw M, Scalia GM, Guerrero M, Pearson P, Kapadia S, Gillinov M, Pichard A, Corso P, Popma J, Chuang M, Blanke P, Leipsic J, Sorajja P; Tendyne Global Feasibility Trial Investigators. Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial. J Am Coll Cardiol. 2017 Jan 31;69(4):381-391. doi: 10.1016/j.jacc.2016.10.068. Epub 2016 Dec 28.
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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.
40 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendyne Mitral Valve System in people with Mitral Valve Regurgitation, run by Abbott Medical Devices at 40 sites in 10 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 28 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 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Germany, France, Italy, Australia and 5 more countries. 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?
Yes. Results are posted in the registry (first posted 2 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs) (time frame: 30 days post-index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02321514, which also lists 2 linked publications.
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 17 Jul 2025.