Cardiovascular Diseases, Heart Valve Calcification, Heart Valve Diseases, Mitral Annular Calcification, Mitral Annulus Calcification, Mitral Insufficiency, Mitral Regurgitation, Mitral Valve Disease, Valve Heart Disease
Conditions
Brief summary
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
Interventions
Mitral valve replacement
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Heart Team determines subject is not a suitable candidate for conventional surgical treatment due to degree of MAC present and the subject will likely benefit from transcatheter valve implantation 2. Symptomatic, severe mitral regurgitation, as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR 3. NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory) 4. Age 18 years or older at time of consent 5. Not a member of a vulnerable population per the investigator's judgment 6. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions, including complying with study required testing and follow-up visits, and has provided written informed consent
Exclusion criteria
1. Presence of Left Ventricle or Left Atrium thrombus 2. Chest condition that prevents transapical access 3. Left Ventricular Ejection Fraction (LVEF) less than 25% assessed by echocardiogram 4. Left Ventricular End Diastolic Dimension (LVEDD) \> 7.0 cm 5. Severe mitral stenosis not amenable to balloon valvuloplasty or transcatheter therapy 6. Prior intervention with permanently implanted mitral device (e.g. MitraClip) 7. Mitral pathoanatomy and Left Ventricular Outflow tract (LVOT) anatomy deemed not suitable for Tendyne mitral valve implantation 8. Any planned cardiac surgery or intervention that is 30 days prior and 30 days post that is not concomitant with the Tendyne procedure 9. Cardiac resynchronization therapy (CRT) device or implantable pulse generator (IPG) implanted within three months of planned implant procedure 10. Myocardial Infarction (MI) within 30 days of the planned implant procedure 11. Symptomatic, or ischemia-associated coronary artery disease (e.g., active ischemia) amenable to revascularization and thus requiring stenting or CABG 12. Cerebrovascular accident (CVA) within six months of planned implant procedure 13. Unresolved severe symptomatic carotid stenosis (\> 70% by ultrasound) 14. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices within 1 month prior to planned implant procedure 15. Severe tricuspid regurgitation or severe right ventricular dysfunction 16. 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 17. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated 18. History of endocarditis within 6 months of planned implant procedure 19. Active systemic infection requiring antibiotic therapy 20. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation therapy) which cannot be adequately managed medically 21. Subject unable or unwilling to take anticoagulation with warfarin for a minimum of 6 months following Tendyne valve implantation 22. Known hypersensitivity to nickel or titanium 23. Subject is undergoing hemodialysis due to chronic renal failure ( ≥ Stage 4 CKD) 24. Subject has pulmonary arterial hypertension (fixed PAS \>70mmHg) 25. FEV1 \< 50% of predicted or \< 1L 26. Subject refuses blood transfusions 27. Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use 28. Pregnant, lactating, or planning pregnancy within next 12 months. 29. Currently participating in an investigational drug or another device trial that has not reached its primary endpoint 30. Subjects with non-cardiac co-morbidities that are likely to result in a life expectancy of less than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC) | 30 days post implant | Definition of Device Success: All of the following must be present: 1. Absence of procedural mortality or stroke; and 2. Proper placement and positioning of the device, and 3. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and 4. Continued intended safety and performance of the device, including: i. No evidence of structural or functional failure ii. No specific device-related technical failure issues or complications iii. Reduction of MR to either optimal or acceptable levels without significant structural valve dysfunction and with no greater than mild (1+) paravalvular MR (and without associated hemolysis). All device- or procedure-related adverse events will be adjudicated by an independent clinical events committee |
Countries
United States
Participant flow
Recruitment details
The study was initially designed to register up to 30 patients from 10 investigational sites in the U.S. However only 11 patients were actually registered and underwent successful implantation with Tendyne TMVI device. Of the 11 patients, 10 patients completed 30-day follow-up, while the remaining one patient died 18 days after the implant procedure
Participants by arm
| Arm | Count |
|---|---|
| Device Arm All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Device Arm |
|---|---|
| Age, Continuous | 78.2 years STANDARD_DEVIATION 5.8 |
| Age, Customized 18-75 years | 4 participants |
| Age, Customized >75 years | 7 participants |
| Body Mass Index | 25.3 kg/m^2 STANDARD_DEVIATION 5.9 |
| Coronary Artery Disease | 8 Participants |
| History of Hypertension | 10 Participants |
| Kansas City Cardiovascular Questionnaire | 46.0 units on a scale STANDARD_DEVIATION 20.1 |
| LV Measurement Left Ventricular End Diastolic Diameter (LVEDD) | 5.2 cm STANDARD_DEVIATION 0.4 |
| LV Measurement Left Ventricular End Diastolic Volume (LVEDV) | 117.3 mL STANDARD_DEVIATION 27.1 |
| LV Measurement Left Ventricular End Systolic Diameter (LVESD) | 3.7 cm STANDARD_DEVIATION 0.6 |
| LV Measurement Left Ventricular End Systolic Volume (LVESV) | 48.7 mL STANDARD_DEVIATION 18.4 |
| NYHA Functional Class NYHA Functional Class I | 0 participants |
| NYHA Functional Class NYHA Functional Class II | 2 participants |
| NYHA Functional Class NYHA Functional Class III | 9 participants |
| NYHA Functional Class NYHA Functional Class IV | 0 participants |
| Peripheral Artery Disease | 6 Participants |
| Predicted Surgical Mortality | 9.03 Probability percentage STANDARD_DEVIATION 8.09 |
| Previous Myocardial Infarction | 3 Participants |
| Prior Coronary Intervention | 8 Participants |
| Prior Valve Intervention | 6 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic/Latino | 10 Participants |
| Race/Ethnicity, Customized White/Caucasian | 10 Participants |
| Region of Enrollment United States | 11 participants |
| Renal Insufficiency (GFR < 60 mL/min/1.73m^2) | 5 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 11 |
| other Total, other adverse events | 7 / 11 |
| serious Total, serious adverse events | 5 / 11 |
Outcome results
Primary
Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC)
Definition of Device Success: All of the following must be present: 1. Absence of procedural mortality or stroke; and 2. Proper placement and positioning of the device, and 3. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and 4. Continued intended safety and performance of the device, including: i. No evidence of structural or functional failure ii. No specific device-related technical failure issues or complications iii. Reduction of MR to either optimal or acceptable levels without significant structural valve dysfunction and with no greater than mild (1+) paravalvular MR (and without associated hemolysis). All device- or procedure-related adverse events will be adjudicated by an independent clinical events committee
Time frame: 30 days post implant
Population: The number of participants analyzed includes all subjects that were registered and implanted in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Arm | Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC) | 7 Participants |