Trial Outcomes & Findings for The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices (NCT NCT03502811)
NCT ID: NCT03502811
Last Updated: 2022-02-16
Results Overview
MAE was defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications (CEC adjudicated).
Recruitment status
COMPLETED
Target enrollment
1041 participants
Primary outcome timeframe
At 30 Days
Results posted on
2022-02-16
Participant Flow
A total of 1041 subjects attempted MitraClip procedure as of the cut-off date of August 5, 2020.
A total of 1045 subjects were screened between April 5, 2018 and March 29, 2019, of which 4 subjects did not have any procedure attempted.
Participant milestones
| Measure |
MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
|
|---|---|
|
Overall Study
STARTED
|
1041
|
|
Overall Study
COMPLETED
|
722
|
|
Overall Study
NOT COMPLETED
|
319
|
Reasons for withdrawal
| Measure |
MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
|
|---|---|
|
Overall Study
Death
|
157
|
|
Overall Study
Withdrawal by Subject
|
105
|
|
Overall Study
Lost to Follow-up
|
26
|
|
Overall Study
No Visits (Missed)
|
31
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MitraClip NTR/XTR System
n=1041 Participants
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
|
|---|---|
|
Age, Continuous
|
77.3 years
STANDARD_DEVIATION 9.7 • n=1041 Participants
|
|
Sex/Gender, Customized
Male
|
571 Participants
n=1041 Participants
|
|
Sex/Gender, Customized
Female
|
470 Participants
n=1041 Participants
|
|
Region of Enrollment
United States
|
420 Participants
n=1041 Participants
|
|
Region of Enrollment
Germany
|
384 Participants
n=1041 Participants
|
|
Region of Enrollment
Israel
|
19 Participants
n=1041 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=1041 Participants
|
|
Region of Enrollment
Spain
|
25 Participants
n=1041 Participants
|
|
Region of Enrollment
Netherlands
|
31 Participants
n=1041 Participants
|
|
Region of Enrollment
Switzerland
|
39 Participants
n=1041 Participants
|
|
Region of Enrollment
Italy
|
120 Participants
n=1041 Participants
|
|
Cardiac Intervention History: Prior Cardiac Surgeries
|
294 Participants
n=1041 Participants
|
PRIMARY outcome
Timeframe: At 30 DaysPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
MAE was defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications (CEC adjudicated).
Outcome measures
| Measure |
MitraClip NTR/XTR System
n=1036 Participants
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
|
|---|---|
|
Safety Measure: Number of Participants With Major Adverse Events (MAE)
All-cause Death (Cardiovascular Death)
|
24 Participants
|
|
Safety Measure: Number of Participants With Major Adverse Events (MAE)
Myocardial Infarction
|
0 Participants
|
|
Safety Measure: Number of Participants With Major Adverse Events (MAE)
Stroke
|
8 Participants
|
|
Safety Measure: Number of Participants With Major Adverse Events (MAE)
Non-elective CV surgeries for device-related complications
|
11 Participants
|
PRIMARY outcome
Timeframe: At 30 daysPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits.
Outcome measures
| Measure |
MitraClip NTR/XTR System
n=864 Participants
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
|
|---|---|
|
Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+
|
845 Participants
|
Adverse Events
MitraClip NTR/XTR System
Serious events: 392 serious events
Other events: 0 other events
Deaths: 157 deaths
Serious adverse events
| Measure |
MitraClip NTR/XTR System
n=1041 participants at risk
Percutaneous mitral valve repair using the MitraClip NTR and XTR system
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIAS NONHAEMOLYTIC AND MARROW DEPRESSION
|
0.58%
6/1041 • Number of events 6 • 1 year
|
|
Blood and lymphatic system disorders
HAEMOLYSES AND RELATED CONDITIONS
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Cardiac disorders
CARDIAC ARRHYTHMIAS
|
5.2%
54/1041 • Number of events 56 • 1 year
|
|
Cardiac disorders
CARDIAC DISORDER SIGNS AND SYMPTOMS
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Cardiac disorders
CARDIAC VALVE DISORDERS
|
3.1%
32/1041 • Number of events 32 • 1 year
|
|
Cardiac disorders
CORONARY ARTERY DISORDERS
|
2.2%
23/1041 • Number of events 26 • 1 year
|
|
Cardiac disorders
HEART FAILURES
|
17.4%
181/1041 • Number of events 250 • 1 year
|
|
Cardiac disorders
MYOCARDIAL DISORDERS
|
0.29%
3/1041 • Number of events 3 • 1 year
|
|
Cardiac disorders
PERICARDIAL DISORDERS
|
0.38%
4/1041 • Number of events 4 • 1 year
|
|
Congenital, familial and genetic disorders
CARDIAC AND VASCULAR DISORDERS CONGENITAL
|
0.29%
3/1041 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGES NEC
|
0.19%
2/1041 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
GASTROINTESTINAL SIGNS AND SYMPTOMS
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
GASTROINTESTINAL STENOSIS AND OBSTRUCTION
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS COMPLICATIONS ASSOCIATED WITH DEVICE
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
General disorders
DEVICE ISSUES
|
0.38%
4/1041 • Number of events 4 • 1 year
|
|
General disorders
FATAL OUTCOMES
|
3.1%
32/1041 • Number of events 32 • 1 year
|
|
General disorders
GENERAL SYSTEM DISORDERS NEC
|
0.58%
6/1041 • Number of events 10 • 1 year
|
|
Hepatobiliary disorders
HEPATIC AND HEPATOBILIARY DISORDERS
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Infections and infestations
INFECTIONS - PATHOGEN UNSPECIFIED
|
1.8%
19/1041 • Number of events 20 • 1 year
|
|
Injury, poisoning and procedural complications
INJURIES NEC
|
0.48%
5/1041 • Number of events 5 • 1 year
|
|
Injury, poisoning and procedural complications
PROCEDURAL RELATED INJURIES AND COMPLICATIONS NEC
|
0.58%
6/1041 • Number of events 6 • 1 year
|
|
Investigations
CARDIAC AND VASCULAR INVESTIGATIONS
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Investigations
HAEMATOLOGY INVESTIGATIONS
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
ELECTROLYTE AND FLUID BALANCE CONDITIONS
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL NEOPLASMS MALIGNANT AND UNSPECIFIED
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIAS
|
0.19%
2/1041 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMAS NON-HODGKIN'S B-CELL
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MISCELLANEOUS AND SITE UNSPECIFIED NEOPLASMS MALIGNANT AND UNSPECIFIED
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
REPRODUCTIVE NEOPLASMS MALE MALIGNANT AND UNSPECIFIED
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
RESPIRATORY AND MEDIASTINAL NEOPLASMS MALIGNANT AND UNSPECIFIED
|
0.19%
2/1041 • Number of events 2 • 1 year
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM VASCULAR DISORDERS
|
2.2%
23/1041 • Number of events 25 • 1 year
|
|
Nervous system disorders
ENCEPHALOPATHIES
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Nervous system disorders
MENTAL IMPAIRMENT DISORDERS
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Nervous system disorders
NEUROLOGICAL DISORDERS NEC
|
0.48%
5/1041 • Number of events 5 • 1 year
|
|
Renal and urinary disorders
NEPHROPATHIES
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
RENAL DISORDERS
|
0.77%
8/1041 • Number of events 8 • 1 year
|
|
Renal and urinary disorders
URINARY TRACT SIGNS AND SYMPTOMS
|
0.19%
2/1041 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL DISORDERS
|
0.19%
2/1041 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
LOWER RESPIRATORY TRACT DISORDERS
|
0.38%
4/1041 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL DISORDERS
|
0.29%
3/1041 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY VASCULAR DISORDERS
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDERS NEC
|
1.7%
18/1041 • Number of events 18 • 1 year
|
|
Surgical and medical procedures
CARDIAC THERAPEUTIC PROCEDURES
|
0.19%
2/1041 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
SOFT TISSUE THERAPEUTIC PROCEDURES
|
0.10%
1/1041 • Number of events 1 • 1 year
|
|
Vascular disorders
ANEURYSMS AND ARTERY DISSECTIONS
|
0.19%
2/1041 • Number of events 2 • 1 year
|
|
Vascular disorders
ARTERIOSCLEROSIS, STENOSIS, VASCULAR INSUFFICIENCY AND NECROSIS
|
0.38%
4/1041 • Number of events 4 • 1 year
|
|
Vascular disorders
DECREASED AND NONSPECIFIC BLOOD PRESSURE DISORDERS AND SHOCK
|
1.2%
12/1041 • Number of events 13 • 1 year
|
|
Vascular disorders
EMBOLISM AND THROMBOSIS
|
0.19%
2/1041 • Number of events 2 • 1 year
|
|
Vascular disorders
VASCULAR DISORDERS NEC
|
0.19%
2/1041 • Number of events 2 • 1 year
|
|
Vascular disorders
VASCULAR HAEMORRHAGIC DISORDERS
|
3.6%
37/1041 • Number of events 38 • 1 year
|
|
Vascular disorders
VASCULAR HYPERTENSIVE DISORDERS
|
0.19%
2/1041 • Number of events 2 • 1 year
|
|
Vascular disorders
VASCULAR INJURIES
|
0.10%
1/1041 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place