Clinical trial NCT01678144: Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
Official title: Evaluation of the Safety and Performance of the Medtentia Mitral Valve Repair System When Used in Adults Undergoing Mitral Valve Repair Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mitral Regurgitation
Mitral Insufficiency
Keywords: mitral valve
mitral surgery
mitral repair
mitral annuloplasty
mitral valve surgery
mitral valve repair
mitral valve annuloplasty
Lead sponsor: Medtentia International Ltd Oy
Sponsor class: INDUSTRY
First posted: 2012-09-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-national, multi-center, open-label, single-arm
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.
timeFrame: Time from surgery through hospital discharge, up to 7 days.
measure: 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).
timeFrame: Time from baseline through V03 (3 months)
Secondary outcomes:
measure: Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.
timeFrame: 30 days, 3 months, 6 months, 1 year, 1.5 years and 2 years after surgery
measure: Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).
timeFrame: From surgery to end of study (2 years)
measure: Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs).
timeFrame: From surgery to end of study (2 years).
measure: Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).
timeFrame: From surgery to end of study (2 years).
measure: Safety: The Occurrence, Frequency and Nature of Abnormalities in the Period From Surgery Through Follow-up (Detailed List in Description Field).
timeFrame: From surgery to end of study (2 years).
measure: Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.
timeFrame: Day of surgery visit (V01).
measure: 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).
timeFrame: V06 (24 months)
Other outcomes:
measure: Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.
timeFrame: From screening to end of study (up to 2 years)
measure: Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.
timeFrame: Day of surgery visit (V01)
measure: Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
timeFrame: At screening and at each follow-up visit (except for discharge visit, up to 2 years).
measure: 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.
timeFrame: Day of surgery visit (V01)
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital, Cardiovascular and Thorax Surgery Clinic
Study officials:
affiliation: Helsinki University Central Hospital
name: Kalervo Werkkala, M.D., Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.