Mitral Regurgitation, Mitral Valve Regurgitation
Conditions
Keywords
MitraClip, MitraClip G4, Mitral Regurgitation
Brief summary
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
Detailed description
This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip G4 System. The current protocol describes the design of this post-market study. Up to 1,100 post-market, consented patients will be treated with a MitraClip G4 device according to local guidelines and IFU from the Europe and Middle East, the United States, Canada and Japan, and will be included in the analysis for the MitraClip EXPAND G4 Study. Follow-up echocardiograms will be collected at Discharge, 30 days and 1 year and 5 year at post-procedure visits. Additional clinical follow-up visits will be at 6 months (phone call), 2, 3, 4 year (office visits). Cardiovascular adverse events will be reported through 5 years to confirm safety of the MitraClip G4 System. During the Phase 1 of the study 100 subjects were enrolled at 15 sites in the United States with the goal of evaluating the early safety and procedural outcomes associated with the MitraClip G4. The follow up duration was 30 days. Phase I was completed August 2020.
Interventions
DEVICEMitraClip G4 System
Percutaneous mitral valve repair using the MitraClip G4 system.
Sponsors
Abbott
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subjects scheduled to receive the MitraClip per the current approved indications for use 2. Subjects who give consent for their participation
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 |
|---|---|---|
| Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days | At 30 days | Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days |
| Occurrence of Major Adverse Events (MAE) at 30 Days | At 30 days | MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With APS | Up to 10 Days | Acute Procedural Success (APS) defined as successful implantation of the MitraClip device with resulting MR severity of 2+ or less on discharge echocardiogram. Echocardiogram (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge are considered to be an APS failure |
| Number of Participants With ADS | Up to 10 Days | Acute Device Success defined as successful implant of the MitraClip device without the occurrence of a Device-Related Complication (including device embolization, Single Leaflet Device Attachment (SLDA), bleeding, or perforation) through discharge. |
| Number of Heart Failure Hospitalization Through 5 Years | Through 5 years | Heart Failure Hospitalization through 5 years |
| Occurrence of In-hospital Major Adverse Events (MAE) | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days | In-hospital Major Adverse Events (MAE) defined as the number of MAEs that occur prior to discharge from hospitalization in which MitraClip Procedure was performed. |
| Rate of All Cause Mortality Through 5 Years | Through 5 years | All Cause Mortality Through 5 years |
| Occurrence of MAE | Through 5 years | Occurrence of Major Adverse Events (MAE) as defined in the protocol through 5 years |
| Percentage of Participants With MR Reduction to ≤1+ or Less at Discharge, 30 Days, 1 and 5 Year | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year | MR Reduction to ≤1+ at Discharge, 30 days, 1 and 5 year |
| Difference Between New York Heart Association (NYHA) at Discharge, 30 Days, 1, 2, 3, 4 and 5 Years, Higher Class Means a Worse Outcome (Class I to IV) | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1, 2, 3, 4 and 5 years | Difference Between NYHA Class at Discharge, 30 days, 1, 2, 3, 4 and 5 years |
| Difference Between Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at 30 Days, 1, 2, 3, 4 and 5 Year, Higher Score Means a Better Outcome (0-100) | 30 days, 1, 2, 3, 4 and 5 year | Difference Between QOL at 30 days, 1, 2, 3, 4 and 5 year |
| Difference Between 6 Minutes Walk Distance (6MWD) at 30 Days, 1 and 5 Year | 30 days, 1, 2, 3, 4 and 5 year | Difference Between 6MWD at 30 days, 1, 2, 3, 4 and 5 year |
| Percentage of Participants With MR Reduction to ≤2+ or Less at Discharge, 30 Days, 1 and 5 Year | Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year | MR Reduction to ≤2+ at Discharge, 30 days, 1 and 5 year |
| Rate of Device Related Complications as Defined in the Protocol Through 5 Years | Through 5 years | Device Related Complications as defined in the protocol through 5 years |
Countries
Canada, France, Germany, Israel, Italy, Japan, Netherlands, Saudi Arabia, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MitraClip G4 System Percutaneous mitral valve repair using the MitraClip G4 system
MitraClip G4 System: Percutaneous mitral valve repair using the MitraClip G4 system. | 1,164 |
| Total | 1,164 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 16 |
| Overall Study | Expected Visits | 15 |
| Overall Study | Missed visits | 61 |
| Overall Study | Withdrawal by Subject | 19 |
Baseline characteristics
| Characteristic | MitraClip G4 System | — |
|---|---|---|
| Age, Continuous | 77.5 years STANDARD_DEVIATION 9.1 | — |
| Body Mass Index | 25.91 kg/m^2 STANDARD_DEVIATION 5.89 | — |
| Coronary Artery Bypass Graft (CABG) | 176 Participants | — |
| Euro Score II | 6.48 points on a scale STANDARD_DEVIATION 6.85 | — |
| Height | 167.78 cm STANDARD_DEVIATION 11.26 | — |
| Permanent Pacemaker | 315 Participants | — |
| Prior Cardiac Interventions (PCI) | 364 Participants | — |
| Prior Cardiac Sugeries | 266 Participants | — |
| Prior Coronary Revascularization | 448 Participants | — |
| Prior Heart Failure Hospitalization within 1 year | 472 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 7 participants | — |
| Region of Enrollment France | 52 participants | — |
| Region of Enrollment Germany | 232 participants | — |
| Region of Enrollment Israel | 10 participants | — |
| Region of Enrollment Italy | 144 participants | — |
| Region of Enrollment Japan | 95 participants | — |
| Region of Enrollment Netherlands | 13 participants | — |
| Region of Enrollment Saudi Arabia | 3 participants | — |
| Region of Enrollment Spain | 22 participants | — |
| Region of Enrollment United States | 586 participants | — |
| Sex: Female, Male Female | 514 Participants | — |
| Sex: Female, Male Male | 650 Participants | — |
| STS Replacement Score | 7.55 percentage STANDARD_DEVIATION 6.21 | — |
| Weight | 73.25 Kg STANDARD_DEVIATION 18.91 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 1,164 |
| other Total, other adverse events | 0 / 1,164 |
| serious Total, serious adverse events | 209 / 1,164 |
Outcome results
Primary
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days
Time frame: At 30 days
Population: All available data has been reported
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip G4 System | Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days | 0+:None | 350 Participants |
| MitraClip G4 System | Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days | 1+: Mild | 547 Participants |
| MitraClip G4 System | Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days | 2+: Moderate | 65 Participants |
| MitraClip G4 System | Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days | 3+: Moderate to Severe | 17 Participants |
| MitraClip G4 System | Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days | 4+: Severe | 4 Participants |
Primary
Occurrence of Major Adverse Events (MAE) at 30 Days
MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications.
Time frame: At 30 days
Population: All available data has been reported
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip G4 System | Occurrence of Major Adverse Events (MAE) at 30 Days | All Cause Death | 16 Participants |
| MitraClip G4 System | Occurrence of Major Adverse Events (MAE) at 30 Days | Myocardial Infarction | 2 Participants |
| MitraClip G4 System | Occurrence of Major Adverse Events (MAE) at 30 Days | Stroke | 6 Participants |
| MitraClip G4 System | Occurrence of Major Adverse Events (MAE) at 30 Days | Non-elective CV Surgery for device related complications | 10 Participants |
Other Pre-specified
Difference Between 6 Minutes Walk Distance (6MWD) at 30 Days, 1 and 5 Year
Difference Between 6MWD at 30 days, 1, 2, 3, 4 and 5 year
Time frame: 30 days, 1, 2, 3, 4 and 5 year
Other Pre-specified
Difference Between Kansas City Cardiomyopathy Questionnaire (KCCQ) Score at 30 Days, 1, 2, 3, 4 and 5 Year, Higher Score Means a Better Outcome (0-100)
Difference Between QOL at 30 days, 1, 2, 3, 4 and 5 year
Time frame: 30 days, 1, 2, 3, 4 and 5 year
Other Pre-specified
Difference Between New York Heart Association (NYHA) at Discharge, 30 Days, 1, 2, 3, 4 and 5 Years, Higher Class Means a Worse Outcome (Class I to IV)
Difference Between NYHA Class at Discharge, 30 days, 1, 2, 3, 4 and 5 years
Time frame: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1, 2, 3, 4 and 5 years
Other Pre-specified
Number of Heart Failure Hospitalization Through 5 Years
Heart Failure Hospitalization through 5 years
Time frame: Through 5 years
Other Pre-specified
Number of Participants With ADS
Acute Device Success defined as successful implant of the MitraClip device without the occurrence of a Device-Related Complication (including device embolization, Single Leaflet Device Attachment (SLDA), bleeding, or perforation) through discharge.
Time frame: Up to 10 Days
Population: All available data has been reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip G4 System | Number of Participants With ADS | 1118 Participants |
Other Pre-specified
Number of Participants With APS
Acute Procedural Success (APS) defined as successful implantation of the MitraClip device with resulting MR severity of 2+ or less on discharge echocardiogram. Echocardiogram (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo mitral valve surgery before discharge are considered to be an APS failure
Time frame: Up to 10 Days
Population: All available data has been reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip G4 System | Number of Participants With APS | 1119 Participants |
Other Pre-specified
Occurrence of In-hospital Major Adverse Events (MAE)
In-hospital Major Adverse Events (MAE) defined as the number of MAEs that occur prior to discharge from hospitalization in which MitraClip Procedure was performed.
Time frame: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip G4 System | Occurrence of In-hospital Major Adverse Events (MAE) | All Cause Death | 9 Participants |
| MitraClip G4 System | Occurrence of In-hospital Major Adverse Events (MAE) | Myocardial Infarction | 0 Participants |
| MitraClip G4 System | Occurrence of In-hospital Major Adverse Events (MAE) | Stroke | 3 Participants |
| MitraClip G4 System | Occurrence of In-hospital Major Adverse Events (MAE) | Non-elective CV surgery for device related complications | 9 Participants |
Other Pre-specified
Occurrence of MAE
Occurrence of Major Adverse Events (MAE) as defined in the protocol through 5 years
Time frame: Through 5 years
Other Pre-specified
Percentage of Participants With MR Reduction to ≤1+ or Less at Discharge, 30 Days, 1 and 5 Year
MR Reduction to ≤1+ at Discharge, 30 days, 1 and 5 year
Time frame: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year
Other Pre-specified
Percentage of Participants With MR Reduction to ≤2+ or Less at Discharge, 30 Days, 1 and 5 Year
MR Reduction to ≤2+ at Discharge, 30 days, 1 and 5 year
Time frame: Through time the subject is discharged from the hospital post-procedure, the average time ranges between 1-6 days, and at 30 days, 1 and 5 year
Other Pre-specified
Rate of All Cause Mortality Through 5 Years
All Cause Mortality Through 5 years
Time frame: Through 5 years
Other Pre-specified
Rate of Device Related Complications as Defined in the Protocol Through 5 Years
Device Related Complications as defined in the protocol through 5 years
Time frame: Through 5 years