Trial Outcomes & Findings for MitraClip NT System Post-marketing Surveillance Study - Japan (NCT NCT03500692)
NCT ID: NCT03500692
Last Updated: 2024-07-23
Results Overview
SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device
Recruitment status
COMPLETED
Target enrollment
500 participants
Primary outcome timeframe
up to 30 Days
Results posted on
2024-07-23
Participant Flow
A total of 500 subjects were enrolled at 40 sites April 2, 2018 to March 31, 2020.
Participant milestones
| Measure |
MitraClip NT System
Percutaneous mitral valve repair using MitraClip NT System
MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
|
|---|---|
|
Overall Study
STARTED
|
500
|
|
Overall Study
COMPLETED
|
259
|
|
Overall Study
NOT COMPLETED
|
241
|
Reasons for withdrawal
| Measure |
MitraClip NT System
Percutaneous mitral valve repair using MitraClip NT System
MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
|
|---|---|
|
Overall Study
Death
|
163
|
|
Overall Study
Lost to Follow-up
|
75
|
|
Overall Study
Termination Reasons
|
3
|
Baseline Characteristics
All available data has been presented.
Baseline characteristics by cohort
| Measure |
MitraClip NT System
n=500 Participants
Percutaneous mitral valve repair using MitraClip NT System
MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
|
|---|---|
|
Age, Continuous
|
77.92 Years
STANDARD_DEVIATION 9.48 • n=500 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=500 Participants
|
|
Sex: Female, Male
Male
|
294 Participants
n=500 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=500 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
500 Participants
n=500 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=500 Participants
|
|
Region of Enrollment
Japan
|
500 participants
n=500 Participants
|
|
Height
|
156.96 Centimeters
STANDARD_DEVIATION 10.02 • n=500 Participants
|
|
Weight
|
52.05 Kilograms
STANDARD_DEVIATION 10.68 • n=500 Participants
|
|
Body Mass Index
|
21.01 Kg/m^2
STANDARD_DEVIATION 3.22 • n=500 Participants
|
|
Society of Thoracic Surgeons (STS) Score
|
11.95 Percentage of Expected Mortality
STANDARD_DEVIATION 9.66 • n=500 Participants
|
|
Cardiovascular History
Dyslipidemia
|
216 Participants
n=498 Participants • All available data has been presented.
|
|
Cardiovascular History
Hypertension
|
300 Participants
n=500 Participants • All available data has been presented.
|
|
Cardiovascular History
Prior Transient Ischemic Attack (TIA)
|
13 Participants
n=492 Participants • All available data has been presented.
|
|
Cardiovascular History
Prior Cerebrovascular Accident (CVA)
|
89 Participants
n=496 Participants • All available data has been presented.
|
|
Cardiovascular History
Prior Myocardial Infarction
|
124 Participants
n=494 Participants • All available data has been presented.
|
|
Cardiovascular History
Cardiac Arrhythmia
|
358 Participants
n=495 Participants • All available data has been presented.
|
|
Cardiovascular History
Atrial Fibrillation
|
316 Participants
n=357 Participants • All available data has been presented.
|
|
Cardiac Intervention History
Prior Cardiac Surgeries
|
89 Participants
n=500 Participants • All available data has been reported.
|
|
Cardiac Intervention History
Percutaneous Coronary Interventions
|
142 Participants
n=493 Participants • All available data has been reported.
|
|
Cardiac Intervention History
CRT/CRT-D
|
86 Participants
n=497 Participants • All available data has been reported.
|
|
Co-Morbidity
Currently Smoking
|
30 Participants
n=492 Participants • All available data has been reported
|
|
Co-Morbidity
Diabetes
|
144 Participants
n=498 Participants • All available data has been reported
|
|
Co-Morbidity
Renal Failure
|
244 Participants
n=497 Participants • All available data has been reported
|
|
Co-Morbidity
Chronic Lung Diesase
|
77 Participants
n=489 Participants • All available data has been reported
|
|
Co-Morbidity
Peripheral Artery Disease
|
56 Participants
n=494 Participants • All available data has been reported
|
|
Co-Morbidity
Prior Major Bleeding
|
13 Participants
n=494 Participants • All available data has been reported
|
|
Co-Morbidity
Cirrhosis
|
6 Participants
n=497 Participants • All available data has been reported
|
|
Co-Morbidity
Cancer
|
66 Participants
n=498 Participants • All available data has been reported
|
|
Heart Valve Intervention
|
28 Participants
n=500 Participants
|
|
Prior Heart Failure Hospitalization Within 1 year
|
321 Participants
n=499 Participants • All available data has been reported.
|
|
Baseline Etiology of Mitral Regurgitation
Degenerative MR Only
|
126 Participants
n=500 Participants
|
|
Baseline Etiology of Mitral Regurgitation
Functional MR Only
|
358 Participants
n=500 Participants
|
|
Baseline Etiology of Mitral Regurgitation
Mixed
|
16 Participants
n=500 Participants
|
|
Baseline Effective Regurgitant Orifice Area
|
0.40 cm^2
STANDARD_DEVIATION 0.26 • n=460 Participants • Data was not available for all the subjects.
|
|
Regurgitant Volume
|
58.04 mL/beat
STANDARD_DEVIATION 27.61 • n=461 Participants • Data was not available for all the subjects.
|
|
Left Ventricular Ejection Fraction (LVEF)
|
46.10 Percentage Of Ejection Fraction
STANDARD_DEVIATION 14.93 • n=499 Participants • All available data has been reported.
|
|
Left Ventricular End Systolic Volume (LVESV)
|
93.54 mL
STANDARD_DEVIATION 64.43 • n=458 Participants • All available data has been reported.
|
|
Left Ventricular End Diastolic Volume (LVEDV)
|
160.26 mL
STANDARD_DEVIATION 75.31 • n=451 Participants • All available data has been reported.
|
|
Serum Creatinine
|
1.71 mg/dl
STANDARD_DEVIATION 1.54 • n=498 Participants • All available data has been reported.
|
|
Brain Natriuretic Peptide (BNP)
|
567.11 pg/mL
STANDARD_DEVIATION 766.67 • n=407 Participants • All available data has been reported
|
|
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)
|
6808.17 Pg/mL
STANDARD_DEVIATION 17329.44 • n=173 Participants • All available data has been reported
|
PRIMARY outcome
Timeframe: up to 30 DaysPopulation: All subjects with available data were included for analysis.
SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device
Outcome measures
| Measure |
MitraClip NT System
n=497 Participants
Percutaneous mitral valve repair using MitraClip NT System
MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
|
|---|---|
|
Single Leaflet Device Attachment (SLDA) Rate
|
1.21 percentage of SLDAs
|
PRIMARY outcome
Timeframe: up to 7 days (Discharge visit) from Procedure datePopulation: All subjects with available data were used for analysis.
APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment. Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Outcome measures
| Measure |
MitraClip NT System
n=496 Participants
Percutaneous mitral valve repair using MitraClip NT System
MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
|
|---|---|
|
No of Participants With Acute Procedural Success (APS)
|
452 Participants
|
Adverse Events
MitraClip NT System
Serious events: 322 serious events
Other events: 25 other events
Deaths: 163 deaths
Serious adverse events
| Measure |
MitraClip NT System
n=500 participants at risk
Percutaneous mitral valve repair using MitraClip NT System
MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
|
|---|---|
|
Cardiac disorders
Atrial Tachycardia
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Atrial Thrombosis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Cardiac Arrest
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Cardiac Failure
|
28.4%
142/500 • Number of events 241 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Chordae Tendinae Rupture
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
4.8%
24/500 • Number of events 24 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Mitral Valve Prolapse
|
1.8%
9/500 • Number of events 9 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Mitral Valve Stenosis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Pericardial Effusion
|
1.0%
5/500 • Number of events 5 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.80%
4/500 • Number of events 4 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Angina Pectoris
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Angina Unstable
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Arrhythmia
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.4%
12/500 • Number of events 17 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Sinus Arrest
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.80%
4/500 • Number of events 5 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Ventricular Tachycardia
|
2.6%
13/500 • Number of events 17 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
1.6%
8/500 • Number of events 8 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Endocrine disorders
Basedow's Disease
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Eye disorders
Cataract
|
0.80%
4/500 • Number of events 4 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Eye disorders
Glaucoma
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Breath Odour
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Ileus
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Oesophageal Perforation
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Death
|
5.8%
29/500 • Number of events 29 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Multi-Organ Failure
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Sudden Cardiac Death
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Hepatobiliary disorders
Cholangitis Acute
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Appendicitis Perforated
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Bacteraemia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Bronchopneumonia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Endocarditis
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Herpes Zoster
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Infection
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Meningitis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Pneumonia
|
4.0%
20/500 • Number of events 21 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Psoas Abscess
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Pyelonephritis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Sepsis
|
1.6%
8/500 • Number of events 8 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Septic Shock
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Staphylococcal Infection
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Urinary Tract Infection
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
0.80%
4/500 • Number of events 4 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.0%
5/500 • Number of events 5 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Spinal Cord Injury Cervical
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Venous Injury
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
6/500 • Number of events 6 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.20%
1/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.40%
2/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
1.2%
6/500 • Number of events 6 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Nervous system disorders
Hypoglycaemic Coma
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Nervous system disorders
Ischaemic Stroke
|
1.8%
9/500 • Number of events 10 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Psychiatric disorders
Depression
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Renal and urinary disorders
Azotaemia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Renal and urinary disorders
Renal Failure
|
5.0%
25/500 • Number of events 25 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.80%
4/500 • Number of events 4 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.80%
4/500 • Number of events 6 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.80%
4/500 • Number of events 4 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
2.6%
13/500 • Number of events 14 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein Purpura
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Surgical and medical procedures
Cardiac Pacemaker Replacement
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Surgical and medical procedures
Haemodialysis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Aortic Dissection
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Arteriosclerosis
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Embolism
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Haemorrhage
|
3.8%
19/500 • Number of events 19 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.40%
2/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Peripheral Embolism
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Thrombosis
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Myocardial Infarction
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Ventricular Dyssynchrony
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Enteritis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.20%
1/500 • Number of events 4 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Device Battery Issue
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Device Deployment Issue
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Device Power Source Issue
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Hernia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Implant Site Haemorrhage
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Pyrexia
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Sudden Death
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Cellulitis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Device Related Sepsis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Tooth Abscess
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Heat Stroke
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Investigations
International Normalised Ratio Increased
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma In Situ Of Eye
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Carcinoma
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Nervous system disorders
Encephalitis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Nervous system disorders
Epilepsy
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.20%
1/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Surgical and medical procedures
Central Venous Catheterisation
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Surgical and medical procedures
Implantable Defibrillator Insertion
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Surgical and medical procedures
Leg Amputation
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Aortic Stenosis
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Aortic Valve Disease
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
Other adverse events
| Measure |
MitraClip NT System
n=500 participants at risk
Percutaneous mitral valve repair using MitraClip NT System
MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Bradycardia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Cardiac Failure
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Chordae Tendinae Rupture
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.60%
3/500 • Number of events 3 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Mitral Valve Prolapse
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Mitral Valve Stenosis
|
0.80%
4/500 • Number of events 5 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Pericardial Effusion
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Tachycardia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Influenza
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Infections and infestations
Pneumonia
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Hypotension
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Vascular disorders
Thrombosis
|
0.40%
2/500 • Number of events 2 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
|
General disorders
Device Deployment Issue
|
0.20%
1/500 • Number of events 1 • This section includes Adverse events reported through 3 years. Subject follow-up is complete.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place