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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01678144
Recruitment Status : Completed
First Posted : September 3, 2012
Last Update Posted : December 22, 2016
Information provided by (Responsible Party):
Medtentia International Ltd Oy

Brief Summary:
The purpose of the trial is to demonstrate the safety, performance and implantability 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 Mitral Valve Prolapse Device: Mitral valve repair using Medentia Annuloplasty Ring Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
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
Study Start Date : June 2011
Actual Primary Completion Date : April 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. All cause mortality [ Time Frame: At hospital discharge after surgery ]
    To evaluate the safety of using the MAR and its accessories for mitral valve repair surgery, in terms of survival from surgery to hospital discharge

  2. Change in mitral regurgitation from baseline to three months as measured by trans thoracic ECHO (echocardiography) [ Time Frame: 3 months after surgery ]
    Success will be defined as an improvement in at least 2 degrees in mitral regurgitation class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease

Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: At 30 days, 3 months, 6 months,1 year, 1,5 years and 2 years after surgery ]
  2. Occurrence frequency and timing of treatment-emergent major adverse cardiac events [ Time Frame: From surgery to end of study (2 years) ]
    Defined as stroke and clinically significant myocardial infarction

  3. Mitral regurgitation as seen in trans esophageal ECHO performed during surgery before and after annuloplasty [ Time Frame: During surgery before and after the implantation ]
  4. Mitral regurgitation measured with trans thoracic ECHO [ Time Frame: From 3 months until end of study (2 years) ]
  5. Occurrence, nature and frequency of treatment-emergent AEs, in particular severe SADEs [ Time Frame: From surgery until end of study (2 years) ]

Other Outcome Measures:
  1. Change on defined MR parameters, as measured using trans thoracic ECHO [ Time Frame: At screening and at each follow-up visit ]
    Defined as MR class (none, trivial, mild, moderate, severe), Left ventricle reverse remodeling, Coaptation height

  2. Duration of the key stages of the annuloplasty procedure in minutes and seconds [ Time Frame: During surgery ]
    MAR implantation time, MAR rotation time, Suturing time, Aortic clamp time, Cardiac arrest time.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed consent form signed by the subjects.
  • Candidate for mitral repair surgery according to European guidelines from the European Society of Cardiology (ESC)/US guideline from the American Heart Association (AHA).
  • Technically feasible potential candidate for MAR implantation (appropriate ring size confirmed and selected during surgery).
  • Life expectancy more than 24 months.
  • Subjects able to attend all scheduled visits and comply with all study procedures.

Exclusion Criteria:

  • Any previous cardiac surgery.
  • Have ejection fraction below 30%
  • Subjects to undergo concomitant cardiac repair or replacement other than CABG, tricuspid valve repair and ablation therapy for correction of atrial fibrillation.
  • Have any structural hindrance that would make use of the MAR technically infeasible
  • Evidence of acute MI within 30 days of the intended mitral valve surgery .
  • History of stroke within the last 12 months or stroke that has caused major neurological dysfunction and/or significant carotid artery disease (subjects with carotid stenosis ≥50% and/or ulceration).
  • Recent or evolving bacterial endocarditis or subjects under antibiotic therapy.
  • 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.
  • Subjects in whom transoesophageal ECHO/Doppler is contraindicated.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01678144

Helsinki University Hospital, Cardiovascular and Thorax Surgery Clinic
Helsinki, Finland, 00029
Sponsors and Collaborators
Medtentia International Ltd Oy
Principal Investigator: Kalervo Werkkala, M.D., Prof. Helsinki University Central Hospital

Responsible Party: Medtentia International Ltd Oy Identifier: NCT01678144     History of Changes
Other Study ID Numbers: 2010-040
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016

Keywords provided by Medtentia International Ltd Oy:
mitral valve
mitral surgery
mitral repair
mitral annuloplasty

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Mitral Valve Prolapse
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Heart Valve Prolapse