Mitral Insufficiency, Mitral Regurgitation
Conditions
Keywords
Mitral valve, Mitral surgery, Mitral repair, Mitral annuloplasty, Mitral valve surgery, Mitral valve repair, Mitral valve annuloplasty
Brief summary
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in clinical investigation 2010-040 performed during June 2011 - April 2016.
Interventions
DEVICEMedtentia Annuloplasty Ring (MAR)
Mitral valve repair using the MAR performed in clinical investigation 2010-040
Sponsors
Medtentia International Ltd Oy
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent Form. * Subject had a successful MAR implantation in clinical investigation 2010-040. * Subject is willing to participate in the follow-up study and to comply with the requirements of the Clinical Investigation Plan.
Exclusion criteria
* Subjects who participated in the clinical investigation 2010-040 but had the MAR replaced with another mitral valve repair ring or system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: the Occurrence, Nature and Frequency of Significant Medical Events | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | — |
| Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) | from 2-year follow-up data point to more than 5 years post-procedure | Success will be defined as no change or any improvement in MR class as described in the American College of Cardiology/ American Heart Association (ACC/AHA) Guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: the Occurrence, Nature and Frequency of Adverse Device Effects (ADEs) and/or Device Deficiencies | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | — |
| Safety: Number of Cardiovascular Admissions | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | — |
| Safety: the Number of Subjects With Clinically Significant Abnormal Findings | day of study visit | The number of subjects with clinically significant abnormal findings in TTE, electrocardiography (ECG), or vital signs and type of abnormal findings will be listed and tabulated |
| Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | Defined as assessment of NYHA functional class status at clinical Investigation 2010-040 2-year follow-up visit and at this investigation visit more than 5 years post-procedure Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. |
| Performance: Number of Subjects With Recurrence of Mitral Regurgitation | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | Recurrence of mitral regurgitation is defined as changing of mitral regurgitation to moderate or severe according to ACC/AHA classification determined by TTE |
| Performance: Change in Mitral Regurgitation Parameters (Coaptation Height), as Measured by TTE | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | Change from the clinical investigation 2010-040 2-year follow-up in the coaptation height, as measured by TTE |
| Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | Change from the clinical investigation 2010-040 2-year follow-up in the following MR parameters, as measured by TTE: \- Left ventricle reverse remodeling: left ventricular inner dimension systole and diastole (the dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-systole and end-diastole) |
| Safety: All-Cause Mortality | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | Collected retrospectively |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Re-operation or Mitral Valve Reintervention Due MAR Performance Failure or Malfunction | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure | — |
| Quality of Life Scores as Measured by the 15D© Questionnaire | day of study visit | 15D© questionnaire investigates the standard of quality of life (QOL15D) through a general health assessment and not specific to a particular disease or age. It is a 15-domain (mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality and sexual activity) questionnaire. Each domain score ranges from 1 (no problems) to 5 (extreme problems), with lower scores reflecting better health-related functional status. |
Countries
Finland
Participant flow
Recruitment details
Each MAR patient attended a single visit at the investigational site Mehiläinen hospital, Helsinki, during the period from 08 Nov 2019 to 29 Jan 2020. Maximum of 11 MAR patients who underwent successful MAR implantation and completed 2010-040 clinical investigation were anticipated to be qualifying for this follow-up clinical investigation.
Pre-assignment details
This follow up investigation compared 5-year timepoint data with the 2-year results of 2010-040 investigation, therefore enrollment numbers differ in the Protocol Section (7) and in the Participant Flow (12). 7 MAR patients returned for 2010-040FU5 follow-up visit and 3 of these were with MAR Classic, 1 with MAR Regular and 3 with MAR Expanded.
Participants by arm
| Arm | Count |
|---|---|
| MAR Population Baseline data was presented for this follow-up clinical investigation 2010-040FU5 population (7 participants) which included participants who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040 and were enrolled in this follow-up clinical investigation 2010-040FU5.
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Clinical Investigation 2010-040 | Adverse Event | 1 |
Baseline characteristics
| Characteristic | MAR Population |
|---|---|
| Age, Continuous | 73.3 years STANDARD_DEVIATION 4.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment Finland | 7 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 11 | 0 / 7 |
| other Total, other adverse events | 0 / 0 | 0 / 7 |
| serious Total, serious adverse events | 0 / 0 | 0 / 7 |
Outcome results
Primary
Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE)
Success will be defined as no change or any improvement in MR class as described in the American College of Cardiology/ American Heart Association (ACC/AHA) Guidelines
Time frame: from 2-year follow-up data point to more than 5 years post-procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MAR Population | Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) | I - None/Trivial | 8 Participants |
| MAR Population | Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) | II - Mild | 3 Participants |
| MAR Population | Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) | III - Moderate | 0 Participants |
| MAR Population | Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) | IV - Severe | 0 Participants |
| 2010-040FU5 >5 Years Follow-up | Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) | IV - Severe | 0 Participants |
| 2010-040FU5 >5 Years Follow-up | Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) | I - None/Trivial | 5 Participants |
| 2010-040FU5 >5 Years Follow-up | Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) | III - Moderate | 0 Participants |
| 2010-040FU5 >5 Years Follow-up | Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) | II - Mild | 2 Participants |
Primary
Safety: the Occurrence, Nature and Frequency of Significant Medical Events
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MAR Population | Safety: the Occurrence, Nature and Frequency of Significant Medical Events | 0 Events |
Secondary
Performance: Change in Mitral Regurgitation Parameters (Coaptation Height), as Measured by TTE
Change from the clinical investigation 2010-040 2-year follow-up in the coaptation height, as measured by TTE
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
Population: At clinical investigation 2010-040 2-year follow-up timepoint data was available for 9 of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MAR Population | Performance: Change in Mitral Regurgitation Parameters (Coaptation Height), as Measured by TTE | 7.4 millimeters | Standard Deviation 2.3 |
| 2010-040FU5 >5 Years Follow-up | Performance: Change in Mitral Regurgitation Parameters (Coaptation Height), as Measured by TTE | 3.9 millimeters | Standard Deviation 5.4 |
Secondary
Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE
Change from the clinical investigation 2010-040 2-year follow-up in the following MR parameters, as measured by TTE: \- Left ventricle reverse remodeling: left ventricular inner dimension systole and diastole (the dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-systole and end-diastole)
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| MAR Population | Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE | Left Ventricular Inner Dimension Systole | 38 millimeters |
| MAR Population | Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE | Left Ventricular Inner Dimension Diastole | 51 millimeters |
| 2010-040FU5 >5 Years Follow-up | Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE | Left Ventricular Inner Dimension Systole | 41 millimeters |
| 2010-040FU5 >5 Years Follow-up | Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE | Left Ventricular Inner Dimension Diastole | 56 millimeters |
Secondary
Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit
Defined as assessment of NYHA functional class status at clinical Investigation 2010-040 2-year follow-up visit and at this investigation visit more than 5 years post-procedure Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MAR Population | Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit | Class I | 11 Participants |
| MAR Population | Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit | Class II | 0 Participants |
| MAR Population | Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit | Class III | 0 Participants |
| MAR Population | Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit | Class IV | 0 Participants |
| 2010-040FU5 >5 Years Follow-up | Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit | Class IV | 0 Participants |
| 2010-040FU5 >5 Years Follow-up | Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit | Class I | 1 Participants |
| 2010-040FU5 >5 Years Follow-up | Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit | Class III | 0 Participants |
| 2010-040FU5 >5 Years Follow-up | Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit | Class II | 6 Participants |
Secondary
Performance: Number of Subjects With Recurrence of Mitral Regurgitation
Recurrence of mitral regurgitation is defined as changing of mitral regurgitation to moderate or severe according to ACC/AHA classification determined by TTE
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAR Population | Performance: Number of Subjects With Recurrence of Mitral Regurgitation | 0 Participants |
Secondary
Safety: All-Cause Mortality
Collected retrospectively
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
Population: All-cause mortality data was collected retrospectively since the last visit of clinical investigation 2010-040. During the course of the recruitment it became known that one MAR patient had died and it accounted for 9% of all-cause mortality rate in all 11 MAR patients. The cause of death was noncardiac-related and was not attributed to MAR.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAR Population | Safety: All-Cause Mortality | 1 Participants |
Secondary
Safety: Number of Cardiovascular Admissions
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MAR Population | Safety: Number of Cardiovascular Admissions | 0 Cardiovascular Admissions |
Secondary
Safety: the Number of Subjects With Clinically Significant Abnormal Findings
The number of subjects with clinically significant abnormal findings in TTE, electrocardiography (ECG), or vital signs and type of abnormal findings will be listed and tabulated
Time frame: day of study visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAR Population | Safety: the Number of Subjects With Clinically Significant Abnormal Findings | 0 Participants |
Secondary
Safety: the Occurrence, Nature and Frequency of Adverse Device Effects (ADEs) and/or Device Deficiencies
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MAR Population | Safety: the Occurrence, Nature and Frequency of Adverse Device Effects (ADEs) and/or Device Deficiencies | 0 Events |
Other Pre-specified
Number of Subjects With Re-operation or Mitral Valve Reintervention Due MAR Performance Failure or Malfunction
Time frame: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAR Population | Number of Subjects With Re-operation or Mitral Valve Reintervention Due MAR Performance Failure or Malfunction | 0 Participants |
Other Pre-specified
Quality of Life Scores as Measured by the 15D© Questionnaire
15D© questionnaire investigates the standard of quality of life (QOL15D) through a general health assessment and not specific to a particular disease or age. It is a 15-domain (mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental function, discomfort and symptoms, depression, distress, vitality and sexual activity) questionnaire. Each domain score ranges from 1 (no problems) to 5 (extreme problems), with lower scores reflecting better health-related functional status.
Time frame: day of study visit
Population: Response for quality of life scores for sexual activity domain of 15D© questionnaire received from 6 patients.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Vitality | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Vitality | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Hearing | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Distress | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Vitality | 1 | 2 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Vitality | 2 | 5 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Mobility | 1 | 5 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Mobility | 2 | 2 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Mobility | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Mobility | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Mobility | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Vision | 1 | 5 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Vision | 2 | 2 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Vision | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Vision | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Vision | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Hearing | 1 | 5 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Hearing | 2 | 2 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Hearing | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Hearing | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Breathing | 1 | 3 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Breathing | 2 | 4 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Breathing | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Breathing | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Breathing | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Sleeping | 1 | 5 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Sleeping | 2 | 1 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Sleeping | 3 | 1 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Sleeping | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Sleeping | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Eating | 1 | 7 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Eating | 2 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Eating | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Eating | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Eating | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Speech | 1 | 6 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Speech | 2 | 1 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Speech | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Speech | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Speech | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Excretion | 1 | 6 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Excretion | 2 | 1 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Excretion | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Excretion | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Excretion | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Usual activities | 1 | 4 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Usual activities | 2 | 3 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Usual activities | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Usual activities | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Usual activities | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Mental function | 1 | 3 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Mental function | 2 | 4 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Mental function | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Mental function | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Mental function | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Discomfort and symptoms | 1 | 4 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Discomfort and symptoms | 2 | 3 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Discomfort and symptoms | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Discomfort and symptoms | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Discomfort and symptoms | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Depression | 1 | 4 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Depression | 2 | 3 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Depression | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Depression | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Depression | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Distress | 1 | 4 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Distress | 2 | 3 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Distress | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Distress | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Vitality | 5 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Sexual activity | 1 | 3 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Sexual activity | 2 | 3 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Sexual activity | 3 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Sexual activity | 4 | 0 Participants |
| MAR Population | Quality of Life Scores as Measured by the 15D© Questionnaire | QOL15D-Sexual activity | 5 | 0 Participants |