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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAR population | Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtentia Annuloplasty Ring (MAR) | Device | Mitral valve repair using the MAR performed in clinical investigation 2010-040 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | from 2-year follow-up data point to more than 5 years post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: All-Cause Mortality | Collected retrospectively | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
| Safety: the Occurrence, Nature and Frequency of Adverse Device Effects (ADEs) and/or Device Deficiencies |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Subjects, who underwent mitral valve repair operation with successful MAR implantation in clinical investigation 2010-040.
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| Name | Affiliation | Role |
|---|---|---|
| Tapio Aalto, MD | Mehiläinen hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mehiläinen hospital | Helsinki | 00260 | Finland |
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| Label | URL |
|---|---|
| Medtentia Company Webpage | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Investigation 2010-040 |
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| ||||||||||||||||||
| 2010-040FU5 >5 Years Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety: the Occurrence, Nature and Frequency of Significant Medical Events | Posted | Number | Events | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
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since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure
The occurrence, nature and frequency of adverse device effects (ADEs) and/or device deficiencies (DDs) since the last visit of clinical investigation 2010-040.
Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed for the Clinical Investigation 2010-040 2-year Follow-up group, therefore total number of participants at risk is "0".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinical Investigation 2010-040 2-year Follow-up | Data for MAR population during clinical Investigation 2010-040, 11 participants, collected for the time frame since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure (2010-040FU5) Serious adverse events and other adverse events data collected only for study 2010-040FU5 participants |
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The investigation was limited by its retrospective nature and design. Due to small study sample not all the comparisons of the parameters at the two timepoints (2-year and 5-year follow-up) could be performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olli Keränen / Chief Executive Officer | Medtentia International Ltd Oy | +358 50 3567090 | ok@medtentia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2019 | May 25, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2020 | May 25, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 | 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 | day of study visit |
| 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) | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
| 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. | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
| 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 | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
| 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 | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
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.
| day of study visit |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Posted | Count of Participants | Participants | from 2-year follow-up data point to more than 5 years post-procedure |
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| Secondary | Safety: All-Cause Mortality | Collected retrospectively | 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. | Posted | Count of Participants | Participants | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
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| Secondary | Safety: the Occurrence, Nature and Frequency of Adverse Device Effects (ADEs) and/or Device Deficiencies | Posted | Number | Events | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
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| Secondary | Safety: Number of Cardiovascular Admissions | Posted | Number | Cardiovascular Admissions | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
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| 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 | Posted | Count of Participants | Participants | day of study visit |
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| 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) | Posted | Median | Inter-Quartile Range | millimeters | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
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| 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. | Posted | Count of Participants | Participants | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
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| 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 | Posted | Count of Participants | Participants | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
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| Other Pre-specified | Number of Subjects With Re-operation or Mitral Valve Reintervention Due MAR Performance Failure or Malfunction | Posted | Count of Participants | Participants | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
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| 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. | Response for quality of life scores for sexual activity domain of 15D© questionnaire received from 6 patients. | Posted | Count of Participants | Participants | day of study visit |
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| 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 | At clinical investigation 2010-040 2-year follow-up timepoint data was available for 9 of 11 participants. | Posted | Mean | Standard Deviation | millimeters | since the last visit of clinical investigation 2010-040 to more than 5 years post-procedure |
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| 1 |
| 11 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 2010-040FU5 >5 Years Follow-up | Patient, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040 and were enrolled in clinical investigation 2010-040FU5 Medtentia Annuloplasty Ring (MAR): Mitral valve repair using the MAR performed in clinical investigation 2010-040 | 0 | 7 | 0 | 7 | 0 | 7 |
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| III - Moderate |
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| IV - Severe |
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| Class III |
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| Class IV |
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| 3 |
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| 4 |
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| 5 |
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| QOL15D-Vision |
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| QOL15D-Hearing |
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| QOL15D-Breathing |
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| QOL15D-Sleeping |
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| QOL15D-Eating |
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| QOL15D-Speech |
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| QOL15D-Excretion |
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| QOL15D-Usual activities |
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| QOL15D-Mental function |
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| QOL15D-Discomfort and symptoms |
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| QOL15D-Depression |
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| QOL15D-Distress |
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| QOL15D-Vitality |
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| QOL15D-Sexual activity |
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