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

NCT01678144 | Terminated Results DMC

• 1 other identifier: 2010-040
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation; Mitral Insufficiency

Keywords

mitral valve; mitral surgery; mitral repair; mitral annuloplasty; mitral valve surgery; mitral valve repair; mitral valve annuloplasty

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

• Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).

  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).

  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).

  From surgery to end of study (2 years).

Other Outcomes (4)

• Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.

  From screening to end of study (up to 2 years)

• Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.

  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).

Study Arms (1)

Medtentia Annuloplasty Ring (MAR)

EXPERIMENTAL

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)

Interventions

Mitral valve repair using the Medtentia Annuloplasty Ring (MAR) DEVICE

Medtentia Annuloplasty Ring (MAR)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form.
• 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.
• 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
• Patient must have a life expectancy of more than 24 months at the time of screening, assuming they undergo mitral valve annuloplasty.
• 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.
• Patient must be able and willing to attend all scheduled visits and comply with all study procedures.

You may not qualify if:

• 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.
• Have ejection fraction below 30%.
• 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.
• 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).
• Show evidence of having had an acute myocardial infarction (MI) within the 30 days preceding the mitral valve repair surgery.
• 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).
• Have recent or evolving bacterial endocarditis or be undergoing antibiotic therapy.
• Have restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2.
• Be in need of annular decalcification.
• 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.
• Have a contraindication to trans-esophageal echocardiography (TEE)/ Doppler.
• 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.
• Be currently or have in the preceding 30 days participated in any other study involving an investigational drug or device.
• 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.

Sponsors & Collaborators

• Medtentia International Ltd Oy: lead

Study Sites (1)

Helsinki University Hospital, Cardiovascular and Thorax Surgery Clinic

Helsinki, 00029, Finland

Location

Related Publications (2)

• 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.

  PMID: 23566678 BACKGROUND

• 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.

  PMID: 22437358 BACKGROUND

Related Links

• Medtentia Company Webpage

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Limitations and 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.

Results Point of Contact

• Title: Olli Keränen / CEO
• Organization: Medtentia International Ltd Oy

ok@medtentia.com

+358 50 3567090

Study Officials

• Kalervo Werkkala, M.D., Prof.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-national, multi-center, open-label, single-arm

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: June 30, 2011
• Primary Completion: July 30, 2014
• Study Completion: April 22, 2016
• Last Updated: August 9, 2019
• Results First Posted: August 9, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)