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

Evaluation of the Safety and Performance of the Medtentia Mitral Valve Repair System When Used in Adults Undergoing Mitral Valve Repair Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Mitral Regurgitation; Mitral Insufficiency
• Intervention / Treatment: Device: Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Hospital, Cardiovascular and Thorax Surgery Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
4. Patient must have a life expectancy of more than 24 months at the time of screening, assuming they undergo mitral valve annuloplasty.
5. 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.
6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.		Time from surgery through hospital discharge, up to 7 days.
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).	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 from baseline through V03 (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.	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.	30 days, 3 months, 6 months, 1 year, 1.5 years and 2 years after surgery
Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).	MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.	From surgery to end of study (2 years)
Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs).	All the adverse events reported were non-device related.	From surgery to end of study (2 years).
Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).		From surgery to end of study (2 years).
Safety: The Occurrence, Frequency and Nature of Abnormalities in the Period From Surgery Through Follow-up (Detailed List in Description Field).	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)	From surgery to end of study (2 years).
Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.	Success will be defined as no or only residual mitral regurgitation (MR).	Day of surgery visit (V01).
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).	Measurement analysis at 24 months after successful MAR implantation.	V06 (24 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.	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	From screening to end of study (up to 2 years)
Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.	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	Day of surgery visit (V01)
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).
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)

Collaborators and Investigators

• Sponsor: Medtentia International Ltd Oy
• Investigators: Principal Investigator: Kalervo Werkkala, M.D., Prof., Helsinki University Central Hospital

Publications and helpful links

General Publications

• Konerding MA, Simpanen J, Ihlberg L, Aittomaki 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2011
• Primary Completion (Actual): July 30, 2014
• Study Completion (Actual): April 22, 2016

Study Registration Dates

• First Submitted: August 30, 2012
• First Submitted That Met QC Criteria: August 30, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: mitral valve repair; mitral valve surgery; mitral valve; mitral valve annuloplasty; mitral surgery; mitral repair; mitral annuloplasty
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2010-040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No