Trial Outcomes & Findings for 5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults (NCT NCT04161079)
NCT ID: NCT04161079
Last Updated: 2020-09-28
Results Overview
Recruitment status
COMPLETED
Target enrollment
12 participants
Primary outcome timeframe
since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
Results posted on
2020-09-28
Participant Flow
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.
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.
Participant milestones
| Measure |
MAR Population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
For some of outcome measures it is defined as MAR Population \>5 Years Follow-up Timepoint
|
|---|---|
|
Clinical Investigation 2010-040
STARTED
|
12
|
|
Clinical Investigation 2010-040
COMPLETED
|
11
|
|
Clinical Investigation 2010-040
NOT COMPLETED
|
1
|
|
2010-040FU5 >5 Years Follow-up
STARTED
|
7
|
|
2010-040FU5 >5 Years Follow-up
COMPLETED
|
7
|
|
2010-040FU5 >5 Years Follow-up
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
MAR Population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
For some of outcome measures it is defined as MAR Population \>5 Years Follow-up Timepoint
|
|---|---|
|
Clinical Investigation 2010-040
Adverse Event
|
1
|
Baseline Characteristics
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Baseline characteristics by cohort
| Measure |
MAR Population
n=7 Participants
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.
|
|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 4.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedureOutcome measures
| Measure |
MAR Population
n=7 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Safety: the Occurrence, Nature and Frequency of Significant Medical Events
|
0 Events
|
—
|
PRIMARY outcome
Timeframe: from 2-year follow-up data point to more than 5 years post-procedureSuccess 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
Outcome measures
| Measure |
MAR Population
n=11 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
n=7 Participants
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE)
I - None/Trivial
|
8 Participants
|
5 Participants
|
|
Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE)
II - Mild
|
3 Participants
|
2 Participants
|
|
Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE)
III - Moderate
|
0 Participants
|
0 Participants
|
|
Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE)
IV - Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedurePopulation: 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.
Collected retrospectively
Outcome measures
| Measure |
MAR Population
n=11 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Safety: All-Cause Mortality
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedureOutcome measures
| Measure |
MAR Population
n=7 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Safety: the Occurrence, Nature and Frequency of Adverse Device Effects (ADEs) and/or Device Deficiencies
|
0 Events
|
—
|
SECONDARY outcome
Timeframe: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedureOutcome measures
| Measure |
MAR Population
n=7 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Safety: Number of Cardiovascular Admissions
|
0 Cardiovascular Admissions
|
—
|
SECONDARY outcome
Timeframe: day of study visitThe 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
Outcome measures
| Measure |
MAR Population
n=7 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Safety: the Number of Subjects With Clinically Significant Abnormal Findings
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedureChange 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)
Outcome measures
| Measure |
MAR Population
n=11 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
n=7 Participants
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE
Left Ventricular Inner Dimension Systole
|
38 millimeters
Interval 36.0 to 43.0
|
41 millimeters
Interval 39.0 to 47.0
|
|
Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE
Left Ventricular Inner Dimension Diastole
|
51 millimeters
Interval 49.0 to 52.0
|
56 millimeters
Interval 51.0 to 59.0
|
SECONDARY outcome
Timeframe: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedureDefined 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.
Outcome measures
| Measure |
MAR Population
n=11 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
n=7 Participants
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
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
|
1 Participants
|
|
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
|
6 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
SECONDARY outcome
Timeframe: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedureRecurrence of mitral regurgitation is defined as changing of mitral regurgitation to moderate or severe according to ACC/AHA classification determined by TTE
Outcome measures
| Measure |
MAR Population
n=7 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Performance: Number of Subjects With Recurrence of Mitral Regurgitation
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedurePopulation: At clinical investigation 2010-040 2-year follow-up timepoint data was available for 9 of 11 participants.
Change from the clinical investigation 2010-040 2-year follow-up in the coaptation height, as measured by TTE
Outcome measures
| Measure |
MAR Population
n=9 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
n=7 Participants
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Performance: Change in Mitral Regurgitation Parameters (Coaptation Height), as Measured by TTE
|
7.4 millimeters
Standard Deviation 2.3
|
3.9 millimeters
Standard Deviation 5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: since the last visit of clinical investigation 2010-040 to more than 5 years post-procedureOutcome measures
| Measure |
MAR Population
n=7 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Number of Subjects With Re-operation or Mitral Valve Reintervention Due MAR Performance Failure or Malfunction
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day of study visitPopulation: Response for quality of life scores for sexual activity domain of 15D© questionnaire received from 6 patients.
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.
Outcome measures
| Measure |
MAR Population
n=7 Participants
2010-040FU5 \>5 years follow-up population
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
2010-040FU5 >5 Years Follow-up
Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040
Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040
|
|---|---|---|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Discomfort and symptoms · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Discomfort and symptoms · 1
|
4 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Mobility · 1
|
5 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Mobility · 2
|
2 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Mobility · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Mobility · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Vision · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Hearing · 1
|
5 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Hearing · 2
|
2 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Hearing · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Hearing · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Breathing · 1
|
3 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Breathing · 2
|
4 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Breathing · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Breathing · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Sleeping · 1
|
5 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Sleeping · 2
|
1 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Sleeping · 3
|
1 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Sleeping · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Sleeping · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Eating · 2
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Eating · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Speech · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Speech · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Speech · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Excretion · 1
|
6 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Excretion · 2
|
1 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Excretion · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Usual activities · 1
|
4 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Usual activities · 2
|
3 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Usual activities · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Discomfort and symptoms · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Usual activities · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Mental function · 1
|
3 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Mental function · 2
|
4 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Mental function · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Mental function · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Mental function · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Discomfort and symptoms · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Depression · 1
|
4 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Depression · 2
|
3 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Depression · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Depression · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Depression · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Distress · 2
|
3 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Distress · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Distress · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Distress · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Vitality · 1
|
2 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Vitality · 2
|
5 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Vitality · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Vitality · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Vitality · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Sexual activity · 1
|
3 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Sexual activity · 2
|
3 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Sexual activity · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Sexual activity · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Sexual activity · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Mobility · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Vision · 1
|
5 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Vision · 2
|
2 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Vision · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Vision · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Hearing · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Breathing · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Eating · 1
|
7 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Eating · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Eating · 5
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Speech · 1
|
6 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Speech · 2
|
1 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Excretion · 3
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Excretion · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Usual activities · 4
|
0 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Discomfort and symptoms · 2
|
3 Participants
|
—
|
|
Quality of Life Scores as Measured by the 15D© Questionnaire
QOL15D-Distress · 1
|
4 Participants
|
—
|
Adverse Events
Clinical Investigation 2010-040 2-year Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
2010-040FU5 >5 Years Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Olli Keränen / Chief Executive Officer
Medtentia International Ltd Oy
Phone: +358 50 3567090
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60