Trial Outcomes & Findings for Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification (NCT NCT03539458)
NCT ID: NCT03539458
Last Updated: 2024-11-18
Results Overview
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
COMPLETED
NA
11 participants
30 days post implant
2024-11-18
Participant Flow
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
Participant milestones
| Measure |
Device Arm
All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Device Arm
All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
Baseline characteristics by cohort
| Measure |
Device Arm
n=11 Participants
All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
|
|---|---|
|
Age, Continuous
|
78.2 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Age, Customized
18-75 years
|
4 participants
n=5 Participants
|
|
Age, Customized
>75 years
|
7 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
|
Predicted Surgical Mortality
|
9.03 Probability percentage
STANDARD_DEVIATION 8.09 • n=5 Participants
|
|
Body Mass Index
|
25.3 kg/m^2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Renal Insufficiency (GFR < 60 mL/min/1.73m^2)
|
5 Participants
n=5 Participants
|
|
Peripheral Artery Disease
|
6 Participants
n=5 Participants
|
|
History of Hypertension
|
10 Participants
n=5 Participants
|
|
Coronary Artery Disease
|
8 Participants
n=5 Participants
|
|
Prior Coronary Intervention
|
8 Participants
n=5 Participants
|
|
Previous Myocardial Infarction
|
3 Participants
n=5 Participants
|
|
Prior Valve Intervention
|
6 Participants
n=5 Participants
|
|
LV Measurement
Left Ventricular End Diastolic Volume (LVEDV)
|
117.3 mL
STANDARD_DEVIATION 27.1 • n=5 Participants
|
|
LV Measurement
Left Ventricular End Systolic Volume (LVESV)
|
48.7 mL
STANDARD_DEVIATION 18.4 • n=5 Participants
|
|
LV Measurement
Left Ventricular End Diastolic Diameter (LVEDD)
|
5.2 cm
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
LV Measurement
Left Ventricular End Systolic Diameter (LVESD)
|
3.7 cm
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Kansas City Cardiovascular Questionnaire
|
46.0 units on a scale
STANDARD_DEVIATION 20.1 • n=5 Participants
|
|
NYHA Functional Class
NYHA Functional Class I
|
0 participants
n=5 Participants
|
|
NYHA Functional Class
NYHA Functional Class II
|
2 participants
n=5 Participants
|
|
NYHA Functional Class
NYHA Functional Class III
|
9 participants
n=5 Participants
|
|
NYHA Functional Class
NYHA Functional Class IV
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post implantPopulation: The number of participants analyzed includes all subjects that were registered and implanted in the study.
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
Outcome measures
| Measure |
Device Arm
n=11 Participants
All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
|
|---|---|
|
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
|
Adverse Events
Device Arm
Serious adverse events
| Measure |
Device Arm
n=11 participants at risk
All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
|
|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
18.2%
2/11 • 30 days
|
|
Blood and lymphatic system disorders
Hemolysis
|
9.1%
1/11 • 30 days
|
|
Blood and lymphatic system disorders
Paravalvular Leak
|
9.1%
1/11 • 30 days
|
|
Cardiac disorders
Arrhythmia or conduction disturbance
|
9.1%
1/11 • 30 days
|
|
Cardiac disorders
Worsening Congestive Heart Failure
|
9.1%
1/11 • 30 days
|
|
Gastrointestinal disorders
Mesenteric Ischemia and Hemorrhagic Shock
|
9.1%
1/11 • 30 days
|
|
Nervous system disorders
Stroke/TIA
|
9.1%
1/11 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency/Failure
|
9.1%
1/11 • 30 days
|
Other adverse events
| Measure |
Device Arm
n=11 participants at risk
All subjects will undergo a procedure with the Tendyne Mitral Valve System: Mitral valve replacement
|
|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
18.2%
2/11 • 30 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.2%
2/11 • 30 days
|
|
Cardiac disorders
Arrhythmia or Conduction Disturbance
|
18.2%
2/11 • 30 days
|
|
Cardiac disorders
Heart Failure treated with IV diuretics
|
9.1%
1/11 • 30 days
|
|
Nervous system disorders
Vocal Cord Dysfunction
|
9.1%
1/11 • 30 days
|
|
Renal and urinary disorders
Acute Kidney Injury
|
9.1%
1/11 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dizziness
|
9.1%
1/11 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
18.2%
2/11 • 30 days
|
Additional Information
Reshma Rao, Principal Study Clinical Research Associate
Abbott Vascular Structural Heart
Results disclosure agreements
- Principal investigator is a sponsor employee The investigators will not use study-related data without the written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER