Mitral Regurgitation, Mitral Valve Regurgitation
Conditions
Keywords
MitraClip, MitraClip NTR, MitraClip XTR, Mitral Regurgitation
Brief summary
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.
Detailed description
The data collected in this study will be used to evaluate device outcomes and characterize trends in patient selection for MitraClip therapy in contemporary real-world use. Moreover, the data will be assessed to identify patient or mitral valve anatomical characteristics that may be most appropriate for these next generation devices. The MitraClip EXPAND Study will be conducted on commercial MitraClip NTR System and MitraClip XTR System that have received CE Mark and/or FDA approval as required. Up to 1,000 subjects at a maximum of 60 sites in Europe and the US were initially planned to enroll in the MitraClip EXPAND Study.
Interventions
DEVICEMitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR/XTR system.
Sponsors
Abbott
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who give consent for their participation 2. Subjects scheduled to receive the MitraClip per the current approved indications for use 3. Subjects with Symptomatic MR (≥3+)
Exclusion criteria
1\. Subjects participating in another clinical study that may impact the follow-up or results of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Measure: Number of Participants With Major Adverse Events (MAE) | At 30 Days | 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). |
| Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+ | At 30 days | The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits. |
Countries
Germany, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
A total of 1041 subjects attempted MitraClip procedure as of the cut-off date of August 5, 2020.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| MitraClip NTR/XTR System Percutaneous mitral valve repair using the MitraClip NTR and XTR system | 1,041 |
| Total | 1,041 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 157 |
| Overall Study | Lost to Follow-up | 26 |
| Overall Study | No Visits (Missed) | 31 |
| Overall Study | Withdrawal by Subject | 105 |
Baseline characteristics
| Characteristic | MitraClip NTR/XTR System | — |
|---|---|---|
| Age, Continuous | 77.3 years STANDARD_DEVIATION 9.7 | — |
| Cardiac Intervention History: Prior Cardiac Surgeries | 294 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 384 Participants | — |
| Region of Enrollment Israel | 19 Participants | — |
| Region of Enrollment Italy | 120 Participants | — |
| Region of Enrollment Netherlands | 31 Participants | — |
| Region of Enrollment Spain | 25 Participants | — |
| Region of Enrollment Switzerland | 39 Participants | — |
| Region of Enrollment United Kingdom | 3 Participants | — |
| Region of Enrollment United States | 420 Participants | — |
| Sex/Gender, Customized Female | 470 Participants | — |
| Sex/Gender, Customized Male | 571 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 157 / 1,041 |
| other Total, other adverse events | 0 / 1,041 |
| serious Total, serious adverse events | 392 / 1,041 |
Outcome results
Primary
Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+
The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits.
Time frame: At 30 days
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip NTR/XTR System | Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+ | 845 Participants |
Primary
Safety Measure: Number of Participants With Major Adverse Events (MAE)
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).
Time frame: At 30 Days
Population: The number of participants analyzed includes subjects who were available at that time of analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip NTR/XTR System | Safety Measure: Number of Participants With Major Adverse Events (MAE) | All-cause Death (Cardiovascular Death) | 24 Participants |
| MitraClip NTR/XTR System | Safety Measure: Number of Participants With Major Adverse Events (MAE) | Myocardial Infarction | 0 Participants |
| MitraClip NTR/XTR System | Safety Measure: Number of Participants With Major Adverse Events (MAE) | Stroke | 8 Participants |
| MitraClip NTR/XTR System | Safety Measure: Number of Participants With Major Adverse Events (MAE) | Non-elective CV surgeries for device-related complications | 11 Participants |