Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Disease, Mitral Valve Replacement
Conditions
Keywords
Mitral valve
Brief summary
The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially available valves ranging in size from 16mm to 37mm. 20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access.
Detailed description
The study is a single arm, prospective, non-randomized, multi-center clinical investigation. The objective of this study is to evaluate the safety and effectiveness of the 15mm MHV in subjects five years or less of age with a diseased, damaged, or malfunctioning mitral heart valve. The objective will be evaluated by assessing valve-related adverse events, subject survival, subject growth, and echocardiogram assessment of hemodynamic function through the five year follow-up visit as long as the valve remains implanted.
Interventions
DEVICEMitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve
Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
Inclusion criteria
IDE Cohort - Inclusion Criteria: 1. Subject requires mitral valve replacement.\* 2. Subject's legally authorized representative gives written consent to participate in the clinical study. 3. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study. * Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study other than those noted in the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography | 12 months | Peak gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. |
| Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | 12 months | Valvular regurgitation as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. |
| Primary Safety Endpoint: Rate of Total Valve-related Adverse Events | 12 months | Kaplan-Meier event rates with 95% confidence intervals would be calculated for valve-related adverse events. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included. |
| Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth | 12 months | The Kaplan-Meier method is a statistical method that summarizes the rate at which subjects survive or are free from a specified event. The method uses whether or not a subject had the specified event and their time to the specified event or the end of their follow-up to calculate the rate. Kaplan-Meier event rates with 95% confidence intervals would be calculated for overall survival. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included. |
| Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography | 12 months | Mean gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Weight Percentiles From Baseline to 12 Months | 12 months | Percentiles would be summarized by visit interval from baseline to 12 months for all available data.Summary statistics including number of subjects, mean, standard deviation, and difference between visits were used for this endpoint. |
| Percentage Change in Height Percentiles From Baseline to 12 Months | 12 months | Percentiles would be summarized by visit interval from baseline to 12 months for all available data. Summary statistics including number of subjects, mean and standard deviation are provided at the 12-month visit. |
Countries
United States
Participant flow
Recruitment details
A total of 23 subjects were enrolled at 15 investigational sites. Twenty (20) subjects were enrolled at 14 sites in the IDE cohort. Following completion of enrollment in the IDE cohort, 3 subjects were enrolled at 3 sites in the CAP cohort. All subjects enrolled in the study were followed for up to 5 years post-implant, or until the valve was retired/explanted, whichever occurred first. Enrollment was completed in the IDE cohort on 03 March 2017 and in the CAP cohort on 12 January 2018.
Participants by arm
| Arm | Count |
|---|---|
| Single Device Arm: Mitral Valve Replacement Subjects who underwent mitral valve implantation or replacement using SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 6 |
| Overall Study | Other Reason | 1 |
| Overall Study | Valve explanted | 13 |
Baseline characteristics
| Characteristic | Single Device Arm: Mitral Valve Replacement |
|---|---|
| Age, Continuous | 7.6 Months STANDARD_DEVIATION 6.8 |
| Body Surface Area (BSA) | 0.3 meter square STANDARD_DEVIATION 0.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 60.5 centimeters STANDARD_DEVIATION 9.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 23 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 10 Participants |
| Weight | 5.5 kilograms STANDARD_DEVIATION 1.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 23 |
| other Total, other adverse events | 11 / 23 |
| serious Total, serious adverse events | 19 / 23 |
Outcome results
Primary
Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth
The Kaplan-Meier method is a statistical method that summarizes the rate at which subjects survive or are free from a specified event. The method uses whether or not a subject had the specified event and their time to the specified event or the end of their follow-up to calculate the rate. Kaplan-Meier event rates with 95% confidence intervals would be calculated for overall survival. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included.
Time frame: 12 months
Population: The analysis population included the subjects who were available at the time of evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth | 71.0 percentage of participants |
Primary
Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography
Mean gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.
Time frame: 12 months
Population: The analysis population included the 14 subjects who have completed the 12-month follow-up visit or until the valve was removed/replaced due to anatomical growth, whichever occurred first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography | 7.9 mmHg | Standard Deviation 4.6 |
Primary
Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation
Valvular regurgitation as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.
Time frame: 12 months
Population: The analysis population included the 14 subjects who have completed the 12-month follow-up visit or until the valve was removed/replaced due to anatomical growth, whichever occurred first.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | None | 9 Participants |
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Trivial | 3 Participants |
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Mild (1+) | 1 Participants |
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Moderate (2+) | 1 Participants |
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Moderately Severe (3+) | 0 Participants |
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Severe (4+) | 0 Participants |
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Present/Unknown | 0 Participants |
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Unknown | 0 Participants |
Primary
Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography
Peak gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first.
Time frame: 12 months
Population: The analysis population included the 14 subjects who have completed the 12-month follow-up visit or until the valve was removed/replaced due to anatomical growth, whichever occurred first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Device Arm: Mitral Valve Replacement | Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography | 19.8 mmHg | Standard Deviation 7.6 |
Primary
Primary Safety Endpoint: Rate of Total Valve-related Adverse Events
Kaplan-Meier event rates with 95% confidence intervals would be calculated for valve-related adverse events. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included.
Time frame: 12 months
Population: The analysis population included the subjects who were available at the time of evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Device Arm: Mitral Valve Replacement | Primary Safety Endpoint: Rate of Total Valve-related Adverse Events | 64.3 percentage of participants |
Secondary
Percentage Change in Height Percentiles From Baseline to 12 Months
Percentiles would be summarized by visit interval from baseline to 12 months for all available data. Summary statistics including number of subjects, mean and standard deviation are provided at the 12-month visit.
Time frame: 12 months
Population: The analysis population included the 14 subjects who have completed the 12-month follow-up visit or until the valve was removed/replaced due to anatomical growth, whichever occurred first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Device Arm: Mitral Valve Replacement | Percentage Change in Height Percentiles From Baseline to 12 Months | 59.4 Percentage of change | Standard Deviation 233 |
Secondary
Percentage Change in Weight Percentiles From Baseline to 12 Months
Percentiles would be summarized by visit interval from baseline to 12 months for all available data.Summary statistics including number of subjects, mean, standard deviation, and difference between visits were used for this endpoint.
Time frame: 12 months
Population: The analysis population included the 14 subjects who have completed the 12-month follow-up visit or until the valve was removed/replaced due to anatomical growth, whichever occurred first.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Device Arm: Mitral Valve Replacement | Percentage Change in Weight Percentiles From Baseline to 12 Months | 370.8 Percentage of change | Standard Deviation 812.3 |