Trial Outcomes & Findings for Expanded Clinical Study of the Tendyne Mitral Valve System (NCT NCT02321514)
NCT ID: NCT02321514
Last Updated: 2025-07-17
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
191 participants
Primary outcome timeframe
30 days post-index procedure
Results posted on
2025-07-17
Participant Flow
A total of 191 patients were enrolled and attempted TMVR procedure with Tendyne Mitral Valve System. The first subject was implanted on 24 November 2014. The last subject was implanted on 02 June 2020 and completed the 1-month follow-up evaluation on July 6, 2020.
Participant milestones
| Measure |
Tendyne Mitral Valve System
Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system
|
|---|---|
|
Overall Study
STARTED
|
191
|
|
Overall Study
COMPLETED
|
166
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Tendyne Mitral Valve System
Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system
|
|---|---|
|
Overall Study
Death
|
15
|
|
Overall Study
Missed Visit
|
7
|
|
Overall Study
Study Exit
|
3
|
Baseline Characteristics
Expanded Clinical Study of the Tendyne Mitral Valve System
Baseline characteristics by cohort
| Measure |
Tendyne Mitral Valve System
n=191 Participants
Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system
|
|---|---|
|
Age, Continuous
|
74.1 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
185 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
177 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 Participants
n=5 Participants
|
|
NYHA Class, III/IV
|
133 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days post-index procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
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
Outcome measures
| Measure |
Tendyne Mitral Valve System
n=170 Participants
Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system
|
|---|---|
|
Safety Endpoint: Number of Participants With Composite of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs)
|
120 Participants
|
PRIMARY outcome
Timeframe: 30 days post-index procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
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.
Outcome measures
| Measure |
Tendyne Mitral Valve System
n=158 Participants
Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system
|
|---|---|
|
Performance Endpoint: Number of Participants With MR Grade ≤ 2
|
158 Participants
|
Adverse Events
Tendyne Mitral Valve System
Serious events: 117 serious events
Other events: 123 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Tendyne Mitral Valve System
n=191 participants at risk
Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
4.7%
9/191 • 30 Days
|
|
Vascular disorders
Bleeding complications
|
0.52%
1/191 • 30 Days
|
|
Vascular disorders
Blood loss requiring transfusion
|
6.3%
12/191 • 30 Days
|
|
Cardiac disorders
Cardiac Arrest
|
3.1%
6/191 • 30 Days
|
|
Cardiac disorders
Cardiac Arrhythmia
|
4.2%
8/191 • 30 Days
|
|
Cardiac disorders
Cardiac tamponade
|
0.52%
1/191 • 30 Days
|
|
Cardiac disorders
Conduction defect/cardiac arrhythmia
|
1.0%
2/191 • 30 Days
|
|
Cardiac disorders
Decreased LV function and/or cardiac output
|
2.6%
5/191 • 30 Days
|
|
Cardiac disorders
Device erosion, migration or malposition
|
1.6%
3/191 • 30 Days
|
|
Cardiac disorders
Dizziness
|
0.52%
1/191 • 30 Days
|
|
Cardiac disorders
Endocarditis
|
0.52%
1/191 • 30 Days
|
|
Cardiac disorders
Heart Failure
|
1.0%
2/191 • 30 Days
|
|
Cardiac disorders
Heart Failure, Worsening
|
9.9%
19/191 • 30 Days
|
|
Cardiac disorders
Hypotension
|
4.7%
9/191 • 30 Days
|
|
Cardiac disorders
Infection
|
1.0%
2/191 • 30 Days
|
|
Cardiac disorders
Mitral valve regurgitation, worsening
|
0.52%
1/191 • 30 Days
|
|
Cardiac disorders
Multiple Organ Failure
|
0.52%
1/191 • 30 Days
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
2/191 • 30 Days
|
|
Cardiac disorders
Pain
|
0.52%
1/191 • 30 Days
|
|
Cardiac disorders
Paravalvular leak
|
1.0%
2/191 • 30 Days
|
|
Cardiac disorders
Pericardial effusion
|
0.52%
1/191 • 30 Days
|
|
Cardiac disorders
Pleural Effusion
|
2.1%
4/191 • 30 Days
|
|
Cardiac disorders
Pulmonary edema
|
0.52%
1/191 • 30 Days
|
|
Cardiac disorders
Sepsis
|
0.52%
1/191 • 30 Days
|
|
Cardiac disorders
Shock
|
6.3%
12/191 • 30 Days
|
|
Cardiac disorders
Tachycardia
|
0.52%
1/191 • 30 Days
|
|
Cardiac disorders
Thrombosis, Device
|
1.6%
3/191 • 30 Days
|
|
Vascular disorders
Vascular & access-related complications
|
2.1%
4/191 • 30 Days
|
|
Vascular disorders
Vascular & access-related complications - Transapical
|
1.6%
3/191 • 30 Days
|
|
Cardiac disorders
Other - Cardiovascular
|
1.6%
3/191 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Blood loss not requiring transfusion
|
0.52%
1/191 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Vascular & access-related complications
|
0.52%
1/191 • 30 Days
|
|
Metabolism and nutrition disorders
Abnormal lab values
|
0.52%
1/191 • 30 Days
|
|
Metabolism and nutrition disorders
Renal insufficiency or failure
|
0.52%
1/191 • 30 Days
|
|
Gastrointestinal disorders
Blood loss requiring transfusion
|
2.1%
4/191 • 30 Days
|
|
Gastrointestinal disorders
Cardiac Arrest
|
0.52%
1/191 • 30 Days
|
|
Gastrointestinal disorders
Liver failure
|
1.0%
2/191 • 30 Days
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.52%
1/191 • 30 Days
|
|
Gastrointestinal disorders
Pain
|
0.52%
1/191 • 30 Days
|
|
Gastrointestinal disorders
Sepsis
|
0.52%
1/191 • 30 Days
|
|
Gastrointestinal disorders
Other - Gastrointestinal/Digestive
|
1.6%
3/191 • 30 Days
|
|
Gastrointestinal disorders
Other - Genitourinary
|
0.52%
1/191 • 30 Days
|
|
Renal and urinary disorders
Renal insufficiency or failure
|
7.3%
14/191 • 30 Days
|
|
Renal and urinary disorders
Urinary Tract Infection
|
1.6%
3/191 • 30 Days
|
|
Renal and urinary disorders
Other - Genitourinary
|
0.52%
1/191 • 30 Days
|
|
General disorders
Blood loss not requiring transfusion
|
0.52%
1/191 • 30 Days
|
|
General disorders
HEENT- Blood loss not requiring transfusion
|
0.52%
1/191 • 30 Days
|
|
Blood and lymphatic system disorders
Anemia
|
3.7%
7/191 • 30 Days
|
|
Blood and lymphatic system disorders
Blood loss not requiring transfusion
|
0.52%
1/191 • 30 Days
|
|
Blood and lymphatic system disorders
Blood loss requiring transfusion
|
7.3%
14/191 • 30 Days
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.52%
1/191 • 30 Days
|
|
Blood and lymphatic system disorders
Infection
|
0.52%
1/191 • 30 Days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.52%
1/191 • 30 Days
|
|
Blood and lymphatic system disorders
Shock
|
0.52%
1/191 • 30 Days
|
|
Blood and lymphatic system disorders
Supratherapeutic INR
|
0.52%
1/191 • 30 Days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
6/191 • 30 Days
|
|
Blood and lymphatic system disorders
Other - Cytokine reaction
|
0.52%
1/191 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Other - Rhabdomyolysis
|
0.52%
1/191 • 30 Days
|
|
Nervous system disorders
Altered mental status
|
0.52%
1/191 • 30 Days
|
|
Nervous system disorders
Embolism, Other
|
0.52%
1/191 • 30 Days
|
|
Nervous system disorders
Stroke
|
1.0%
2/191 • 30 Days
|
|
Nervous system disorders
Other - Neurologic
|
1.6%
3/191 • 30 Days
|
|
Psychiatric disorders
Altered mental status
|
0.52%
1/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Blood loss requiring transfusion
|
0.52%
1/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cardiac Arrest
|
0.52%
1/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Heart Failure, Worsening
|
1.0%
2/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Infection
|
1.0%
2/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
7.3%
14/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Difficulty
|
1.6%
3/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Insufficiency/Failure
|
5.8%
11/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Sepsis
|
0.52%
1/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Other - Respiratory
|
2.6%
5/191 • 30 Days
|
|
General disorders
Altered mental status
|
0.52%
1/191 • 30 Days
|
|
General disorders
Anemia
|
0.52%
1/191 • 30 Days
|
|
General disorders
HEENT- Blood loss requiring transfusion
|
0.52%
1/191 • 30 Days
|
|
General disorders
Fever
|
0.52%
1/191 • 30 Days
|
|
General disorders
Infection
|
0.52%
1/191 • 30 Days
|
|
General disorders
Liver failure
|
0.52%
1/191 • 30 Days
|
|
General disorders
Multiple Organ Failure
|
0.52%
1/191 • 30 Days
|
|
General disorders
Pleural Effusion
|
0.52%
1/191 • 30 Days
|
|
General disorders
Renal insufficiency or failure
|
1.6%
3/191 • 30 Days
|
|
General disorders
Sepsis
|
0.52%
1/191 • 30 Days
|
|
General disorders
Vascular & access-related complications
|
0.52%
1/191 • 30 Days
|
|
General disorders
Other - Coagulopathy- clotting disorder
|
0.52%
1/191 • 30 Days
|
|
General disorders
Other - Increased CT output
|
0.52%
1/191 • 30 Days
|
|
General disorders
Other - thoracic drainage
|
0.52%
1/191 • 30 Days
|
|
General disorders
Other - unable to remove chest tube
|
0.52%
1/191 • 30 Days
|
Other adverse events
| Measure |
Tendyne Mitral Valve System
n=191 participants at risk
Tendyne Mitral Valve System
Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
8.4%
16/191 • 30 Days
|
|
Cardiac disorders
Cardiac Arrhythmia
|
8.4%
16/191 • 30 Days
|
|
Cardiac disorders
Decreased LV function and/or cardiac output
|
5.8%
11/191 • 30 Days
|
|
Cardiac disorders
Hypotension
|
9.9%
19/191 • 30 Days
|
|
Cardiac disorders
Paravalvular leak
|
7.3%
14/191 • 30 Days
|
|
Metabolism and nutrition disorders
Abnormal lab values
|
5.2%
10/191 • 30 Days
|
|
Metabolism and nutrition disorders
Fever
|
7.3%
14/191 • 30 Days
|
|
Gastrointestinal disorders
Other - Gastrointestinal/Digestive
|
5.8%
11/191 • 30 Days
|
|
Renal and urinary disorders
Renal insufficiency or failure
|
8.4%
16/191 • 30 Days
|
|
Blood and lymphatic system disorders
Anemia
|
6.8%
13/191 • 30 Days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.2%
10/191 • 30 Days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.9%
19/191 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Pain
|
9.9%
19/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
9.4%
18/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Difficulty
|
5.2%
10/191 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Other - Respiratory
|
12.0%
23/191 • 30 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60