Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation

• Sponsor: Medtentia International Ltd Oy (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01678144
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 57.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty rings.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation; Mitral Insufficiency	Device: Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)	N/A

Detailed Description

The purpose of this study is to evaluate the safety and performance of the MAR in patients with mitral regurgitation requiring either isolated mitral valve annuloplasty or mitral valve annuloplasty concomitantly with any of the following, either individually or in combination:

• Tricuspid valve repair

• Coronary artery bypass grafting (CABG)

• Valve resection and chordae repair

• Correction of atrial septal defect

• Correction of patent foramen ovale

• Ablation therapy for atrial defibrillation

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, multi-national, multi-center, open-label, single-armProspective, multi-national, multi-center, open-label, single-arm
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Safety and Performance of the Medtentia Mitral Valve Repair System When Used in Adults Undergoing Mitral Valve Repair Surgery
• Actual Study Start Date: Jun 30, 2011
• Actual Primary Completion Date: Jul 30, 2014
• Actual Study Completion Date: Apr 22, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Medtentia Annuloplasty Ring (MAR) All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR)	Device: Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)

Outcome Measures

Primary Outcome Measures

1. Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge. [Time from surgery through hospital discharge, up to 7 days.]

2. Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes From Baseline (SC) to Three Months (V03) as Measured by Trans-thoracic Echocardiography (TTE). [Time from baseline through V03 (3 months)]

   Success will be defined as an improvement in at least 2 degrees in mitral regurgitation (MR) class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease (Bonow, et al., 2008).

Secondary Outcome Measures

1. Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years. [30 days, 3 months, 6 months, 1 year, 1.5 years and 2 years after surgery]

   Mortality rates determined both for all-cause mortality and for related deaths only. For the former, the causality status will be determined by the Investigator, and all deaths that are clearly unrelated to the device, the surgery or the underlying medical condition will be excluded from the analysis.

2. Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs). [From surgery to end of study (2 years)]

   MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.

3. Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs). [From surgery to end of study (2 years).]

   All the adverse events reported were non-device related.

4. Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs). [From surgery to end of study (2 years).]

5. Safety: The Occurrence, Frequency and Nature of Abnormalities in the Period From Surgery Through Follow-up (Detailed List in Description Field). [From surgery to end of study (2 years).]

   The occurrence, frequency and nature of abnormalities in any of the following: physical examination vital signs electrocardiography (ECG) echocardiography (ECHO) Laboratory tests Chest X-rays (taken only when clinically indicated)

6. Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty. [Day of surgery visit (V01).]

   Success will be defined as no or only residual mitral regurgitation (MR).

7. Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes at Each Follow-up Visit (V04-V06) of the Improvement in MR From Screening, as Measured by Trans-thoracic Echocardiography (TTE). [V06 (24 months)]

   Measurement analysis at 24 months after successful MAR implantation.

Other Outcome Measures

1. Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE. [From screening to end of study (up to 2 years)]

   Change from screening at each follow-up visit in the following MR parameters, as measured using TTE: Left ventricular inner dimension systole and diastole assessment by trans-thoracic echocardiography (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) Coaptation height

2. Exploratory: Duration of the Key Stages of the Annuloplasty Procedure. [Day of surgery visit (V01)]

   Duration of the following key stages of the annuloplasty procedure: MAR implantation time (beginning with the measurement of the annulus size and ending with the completion of the last suture, but not including the time needed to measure leaflet thickness) MAR rotation time Suturing time (from start of annulus suturing until last knot) Aortic clamp time Cardiac arrest time

3. Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge. [At screening and at each follow-up visit (except for discharge visit, up to 2 years).]

4. Exploratory: Thickness of the Anterior Leaflet Segment A2 and the Posterior Scallop P2 of the Mitral Valve (MV) Leaflets, as Measured With the Dedicated Medtentia Leaflet Measurement Tool. [Day of surgery visit (V01)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

Eligible patients must meet all the following inclusion criteria:

1. Signed Informed Consent Form.

2. Male or female aged ≥18 to ≤ 85 years on the day of screening. Females of childbearing potential (not surgically sterilized or more than one year post-menopausal) must have a negative pregnancy test (serum beta-human chorionic gonadotropin (beta-hCG) or urine) within 24 hours prior to mitral valve surgery.

3. Patient must meet one of the following indications for mitral repair surgery according to the European Society of Cardiology (ESC) and the American Heart Association (AHA) guidelines, and must have consented to have such surgery before undergoing the informed consent process for this study.

• Symptomatic patient with chronic severe primary mitral regurgitation (MR), left ventricle ejection fraction (LVEF) > 30% and left ventricle end systolic diameter (LVESD) < 55 mm or

• Asymptomatic patient with chronic severe primary MR who either:

• Has LV dysfunction (LVEF ≤ 60 % and/or LVESD ≥ 40 mm or

• Has a preserved LV function (LVEF> 60% and LVESD < 40 mm) together with a likelihood of a successful and durable repair of > 95 % and an expected mortality rate of < 1% or

• Has a flail leaflet and LVESD ≥ 40 mm together with a high likelihood of durable repair and a low surgical risk or

• Has a new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary pressure > 50 mm Hg at rest) or

• Asymptomatic patient with chronic moderate or severe primary MR who is to undergo cardiac surgery for another indication when the mitral valve (MV) repair can be performed concomitantly

• Patient with chronic severe or moderate secondary MR and an LVEF > 30 % who is undergoing CABG concomitantly

1. Patient must have a life expectancy of more than 24 months at the time of screening, assuming they undergo mitral valve annuloplasty.

2. Patient must have a mitral valve diameter corresponding to MAR size 26 - 40 and leaflet thickness (smallest helix height - largest helix height) for which an appropriate MAR ring is available.

3. Patient must be able and willing to attend all scheduled visits and comply with all study procedures.

Exclusion criteria:

Eligible patients must not meet any of the following exclusion criteria:

1. Have had previous cardiac surgery, including but not limited to any of the following: minimally invasive surgery, mitral valve surgery or valvuloplasty, implantation of a prosthetic heart valve or cardiac defibrillator.

2. Have ejection fraction below 30%.

3. Plan to have any concomitant cardiac surgery or procedure other than CABG, tricuspid valve repair, correction of atrial septal defect, closure of auricular appendage, correction of patent foramen ovale and/or ablation therapy for correction of atrial fibrillation performed with the mitral valve repair, which may also include leaflet resection and chordae replacement.

4. Have any structural hindrance or heart abnormality that would make use of the MAR technically infeasible, such as a mitral valve of an unusual size or leaflet thickness for which a suitable MAR is not available, or an obstruction or other abnormality that blocks positioning of the MAR. (Final determination to be made during surgery).

5. Show evidence of having had an acute myocardial infarction (MI) within the 30 days preceding the mitral valve repair surgery.

6. Have a history of stroke within the preceding 12 months or have had any stroke that is not completely clinically resolved and/or significant carotid artery disease (subjects with carotid stenosis ≥50% and/or ulceration).

7. Have recent or evolving bacterial endocarditis or be undergoing antibiotic therapy.

8. Have restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2.

9. Be in need of annular decalcification.

10. Have any comorbidities or conditions that would be a contraindication to open heart surgery or that would place the patient at an unacceptable surgical risk, such as: severe chronic obstructive pulmonary disease (COPD); hepatic failure; immunosuppressive abnormalities or other immunological deficiencies including being immunocompromised or having an autoimmune disease; chronic renal failure requiring dialysis; hematological abnormalities including a history of bleeding diathesis or coagulopathy; being unable to follow the locally recommended anticoagulant regimen; an intolerance or hypersensitivity to anesthetics; cancer that requires further radiation, chemotherapy or surgical treatment.

11. Have a contraindication to trans-esophageal echocardiography (TEE)/ Doppler.

12. Have any recent psychiatric disorder, including drug or alcohol abuse, that in the Investigator's opinion could impair the patient's compliance with study procedures.

13. Be currently or have in the preceding 30 days participated in any other study involving an investigational drug or device.

14. Be an employee of the investigational site directly affiliated with this study, the sponsor or the clinical research organization or have an immediate family member who is.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Hospital, Cardiovascular and Thorax Surgery Clinic	Helsinki		Finland	00029

Sponsors and Collaborators

• Medtentia International Ltd Oy

Investigators

• Principal Investigator: Kalervo Werkkala, M.D., Prof., Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Medtentia Company Webpage

Publications

• Jensen H, Simpanen J, Smerup M, Bjerre M, Bramsen M, Werkkala K, Vainikka T, Hasenkam JM, Wierup P. Medtentia double helix mitral annuloplasty system evaluated in a porcine experimental model. Innovations (Phila). 2010 Mar;5(2):114-7. doi: 10.1097/IMI.0b013e3181d84316.
• Konerding MA, Simpanen J, Ihlberg L, Aittomäki J, Werkkala K, Delventhal V, Ackermann M. Comparison of the novel Medtentia double helix mitral annuloplasty system with the Carpentier-Edwards Physio annuloplasty ring: morphological and functional long-term outcome in a mitral valve insufficiency sheep model. J Cardiothorac Surg. 2013 Apr 8;8:70. doi: 10.1186/1749-8090-8-70.

• Responsible Party: Medtentia International Ltd Oy
• ClinicalTrials.gov Identifier: NCT01678144
• Other Study ID Numbers: 2010-040
• First Posted: Sep 3, 2012
• Last Update Posted: Aug 9, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Medtentia International Ltd Oy: mitral valve; mitral surgery; mitral repair; mitral annuloplasty; mitral valve surgery; mitral valve repair; mitral valve annuloplasty
• Additional relevant MeSH terms: Mitral Valve Insufficiency

Study Results

Participant Flow

Recruitment Details	All patients were enrolled at Helsinki University Central Hospital from June 2011 to April 2014. During Stage 1 (2011-2012) and Stage 2 (2013-2016) MAR was implanted for 12 patients. 11 of 24 consented patients did not receive MAR due to non-anatomical fit (majority in Stage 1); for 1 patient MAR was replaced before the operation was completed.
Pre-assignment Detail	Patients qualifying for mitral valve repair surgery according to guidelines from the European Society of Cardiology (ESC) and the American Heart Association (AHA) and meeting pre-operative selection criteria. Successful implantation rate improved significantly during Stage 2 after sizing adjustment of the implant (Regular and Expanded).

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR).
Period Title: Stage 1: MAR Classic
STARTED	7
COMPLETED	6
NOT COMPLETED	1
Period Title: Stage 1: MAR Classic
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR) Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 41.7%
>=65 years	7 58.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.5 (8.3)
Sex: Female, Male (Count of Participants)
Female	3 25%
Male	9 75%
Region of Enrollment (participants) [Number]
Finland	12 100%
New York Heart Association (NYHA) Functional Capacity (participants) [Number]
Class I	2 16.7%
Class II	5 41.7%
Class III	4 33.3%
Class IV	1 8.3%
Left Ventricular Inner Dimension Systole (millimeters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [millimeters]	46
Mitral valve regurgitation (participants) [Number]
Class I	0 0%
Class II	0 0%
Class III	0 0%
Class IV	11 91.7%
Smoking status (Count of Participants)
Current smoker	1 8.3%
Non-smoker/ Former smoker	11 91.7%
Mitral valve leaflet coaptation height (millimeters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [millimeters]	14
Left Ventricular Inner Dimension Diastole (millimeters) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [millimeters]	60

Outcome Measures

1. Primary Outcome

Title	Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.
Time Frame	Time from surgery through hospital discharge, up to 7 days.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	12
Count of Participants [Participants]	0 0%

2. Primary Outcome

Title	Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes From Baseline (SC) to Three Months (V03) as Measured by Trans-thoracic Echocardiography (TTE).
Description	Success will be defined as an improvement in at least 2 degrees in mitral regurgitation (MR) class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease (Bonow, et al., 2008).
Time Frame	Time from baseline through V03 (3 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	11
Mean (95% Confidence Interval) [percentage of participants]	90.91 757.6%

3. Secondary Outcome

Title	Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.
Description	Mortality rates determined both for all-cause mortality and for related deaths only. For the former, the causality status will be determined by the Investigator, and all deaths that are clearly unrelated to the device, the surgery or the underlying medical condition will be excluded from the analysis.
Time Frame	30 days, 3 months, 6 months, 1 year, 1.5 years and 2 years after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	12
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).
Description	MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.
Time Frame	From surgery to end of study (2 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	12
Number [Events]	1

5. Secondary Outcome

Title	Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs).
Description	All the adverse events reported were non-device related.
Time Frame	From surgery to end of study (2 years).

Outcome Measure Data

Analysis Population Description

Due to the smaller than planned patient group size the descriptive statistics was used. Adverse events data is presented in Adverse Events section.

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	12
Number [Events]	30

6. Secondary Outcome

Title	Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).
Time Frame	From surgery to end of study (2 years).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	12
Number [Events]	0

7. Secondary Outcome

Title	Safety: The Occurrence, Frequency and Nature of Abnormalities in the Period From Surgery Through Follow-up (Detailed List in Description Field).
Description	The occurrence, frequency and nature of abnormalities in any of the following: physical examination vital signs electrocardiography (ECG) echocardiography (ECHO) Laboratory tests Chest X-rays (taken only when clinically indicated)
Time Frame	From surgery to end of study (2 years).

Outcome Measure Data

Analysis Population Description

The study was terminated prematurely. Due to the smaller than planned patient group size no sufficient data was collected for planned analysis of this endpoint.

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	0

8. Secondary Outcome

Title	Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.
Description	Success will be defined as no or only residual mitral regurgitation (MR).
Time Frame	Day of surgery visit (V01).

Outcome Measure Data

Analysis Population Description

The data for this outcome measure was not collected.This was a part of the echocardiography investigation protocol and therefore was not documented on electronic case report form although the surgeon in charge performed the investigation on the operation table.

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	0

9. Secondary Outcome

Title	Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes at Each Follow-up Visit (V04-V06) of the Improvement in MR From Screening, as Measured by Trans-thoracic Echocardiography (TTE).
Description	Measurement analysis at 24 months after successful MAR implantation.
Time Frame	V06 (24 months)

Outcome Measure Data

Analysis Population Description

The study was terminated prematurely. Due to the smaller than planned patient group size no patient data at V04 (6 months) and V05 (12 months) was analyzed for this endpoint. The results provided are only for V06 (24 months).

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	11
Mean (95% Confidence Interval) [percentage of participants]	100 833.3%

10. Other Pre-specified Outcome

Title	Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.
Description	Change from screening at each follow-up visit in the following MR parameters, as measured using TTE: Left ventricular inner dimension systole and diastole assessment by trans-thoracic echocardiography (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) Coaptation height
Time Frame	From screening to end of study (up to 2 years)

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects and follow up visits where data is available

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	11
Left Ventricular Inner Dimension Systole 3 months	40
Left Ventricular Inner Dimension Systole 2 years	38
Left Ventricular Inner Dimension Diastole 3 months	50
Left Ventricular Inner Dimension Diastole 2 years	51
Coaptation Height 3 months	6.2
Coaptation Height 2 years	7.3

11. Other Pre-specified Outcome

Title	Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.
Description	Duration of the following key stages of the annuloplasty procedure: MAR implantation time (beginning with the measurement of the annulus size and ending with the completion of the last suture, but not including the time needed to measure leaflet thickness) MAR rotation time Suturing time (from start of annulus suturing until last knot) Aortic clamp time Cardiac arrest time
Time Frame	Day of surgery visit (V01)

Outcome Measure Data

Analysis Population Description

MAR rotation time assessment available for 9 patients only.

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	11
Aortic clamp time	87.2 (24.5)
MAR implantation time	16.9 (5.0)
Suturing time	14.6 (4.1)
MAR rotation time	2.5 (1.4)
Cardiac arrest time	116.2 (32.8)

12. Other Pre-specified Outcome

Title	Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
Time Frame	At screening and at each follow-up visit (except for discharge visit, up to 2 years).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	11
Class I	8 66.7%
Class II	3 25%
Class III	0 0%
Class IV	0 0%
Class I	9 75%
Class II	2 16.7%
Class III	0 0%
Class IV	0 0%
Class I	10 83.3%
Class II	1 8.3%
Class III	0 0%
Class IV	0 0%
Class I	11 91.7%
Class II	0 0%
Class III	0 0%
Class IV	0 0%

13. Other Pre-specified Outcome

Title	Exploratory: Thickness of the Anterior Leaflet Segment A2 and the Posterior Scallop P2 of the Mitral Valve (MV) Leaflets, as Measured With the Dedicated Medtentia Leaflet Measurement Tool.
Time Frame	Day of surgery visit (V01)

Outcome Measure Data

Analysis Population Description

The leaflet measuring tool was designed to compress the leaflet between two jaws to measure the thickness. Due to soft tissue getting compressed between these two jaws the measure was not seen accurate, therefore this procedure was omitted in the study.

Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
Measure Participants	0

Adverse Events

Time Frame	AEs documented from the point of surgery trough the follow-up (2 years).
Adverse Event Reporting Description	Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected. Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.
Arm/Group Title	Medtentia Annuloplasty Ring (MAR)
Arm/Group Description	Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
All Cause Mortality
	Medtentia Annuloplasty Ring (MAR)
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Medtentia Annuloplasty Ring (MAR)
	Affected / at Risk (%)	# Events
Total	7/12 (58.3%)
Cardiac disorders
Residual mitral regurgitation leading to re-operation	1/12 (8.3%)	1
Takotsubo cardiomyopathy	1/12 (8.3%)	1
Atrial fibrillation worsening	1/12 (8.3%)	1
Atrial fibrillation	2/12 (16.7%)	2
Atrial flutter	1/12 (8.3%)	1
Infections and infestations
Peritonsilitis l.dx	1/12 (8.3%)	1
Pneumonia	1/12 (8.3%)	1
Urinary tract infection/ urosepsis	1/12 (8.3%)	1
Injury, poisoning and procedural complications
Postoperative fever	1/12 (8.3%)	1
Investigations
Increased white blood cell count	1/12 (8.3%)	1
Nervous system disorders
Transient ischemic attack	1/12 (8.3%)	1
Pre-symptomatic migraine	1/12 (8.3%)	1
Psychiatric disorders
Postoperative delirium	1/12 (8.3%)	1
Other (Not Including Serious) Adverse Events
	Medtentia Annuloplasty Ring (MAR)
	Affected / at Risk (%)	# Events
Total	8/12 (66.7%)
Cardiac disorders
Atrial fibrillation worsening	2/12 (16.7%)	2
Atrial fibrillation	4/12 (33.3%)	5
Atrial flutter	2/12 (16.7%)	2
Ventricular tachycardia episode	1/12 (8.3%)	1
Infections and infestations
Urinary tract infection	1/12 (8.3%)	1
Wound infection	2/12 (16.7%)	2
Common cold	1/12 (8.3%)	1
Respiratory, thoracic and mediastinal disorders
Asthma bronchiale	1/12 (8.3%)	1
Pulmonary congestion	1/12 (8.3%)	1

Limitations/Caveats

The study was terminated prematurely. The smaller than planned patient group size did not allow testing the study hypothesis in full. Due to the limited number of patients only descriptive statistics were used.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.