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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Medtentia International Ltd Oy
Sponsor:
Information provided by (Responsible Party):
Medtentia International Ltd Oy
ClinicalTrials.gov Identifier:
NCT01678144
First received: August 30, 2012
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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 Intervention
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve Prolapse
Device: Mitral valve repair using Medentia Annuloplasty Ring

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medtentia International Ltd Oy:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: At hospital discharge after surgery ] [ Designated as safety issue: Yes ]
    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

  • Change in mitral regurgitation from baseline to three months as measured by trans thoracic ECHO (echocardiography) [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    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:
  • All cause mortality [ Time Frame: At 30 days, 3 months, 6 months,1 year, 1,5 years and 2 years after surgery ] [ Designated as safety issue: Yes ]
  • Occurrence frequency and timing of treatment-emergent major adverse cardiac events [ Time Frame: From surgery to end of study (2 years) ] [ Designated as safety issue: Yes ]
    Defined as stroke and clinically significant myocardial infarction

  • Mitral regurgitation as seen in trans esophageal ECHO performed during surgery before and after annuloplasty [ Time Frame: During surgery before and after the implantation ] [ Designated as safety issue: No ]
  • Mitral regurgitation measured with trans thoracic ECHO [ Time Frame: From 3 months until end of study (2 years) ] [ Designated as safety issue: No ]
  • Occurrence, nature and frequency of treatment-emergent AEs, in particular severe SADEs [ Time Frame: From surgery until end of study (2 years) ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Change on defined MR parameters, as measured using trans thoracic ECHO [ Time Frame: At screening and at each follow-up visit ] [ Designated as safety issue: No ]
    Defined as MR class (none, trivial, mild, moderate, severe), Left ventricle reverse remodeling, Coaptation height

  • Duration of the key stages of the annuloplasty procedure in minutes and seconds [ Time Frame: During surgery ] [ Designated as safety issue: No ]
    MAR implantation time, MAR rotation time, Suturing time, Aortic clamp time, Cardiac arrest time.


Estimated Enrollment: 230
Study Start Date: June 2011
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678144

Contacts
Contact: Pertti Seppälä +358 40 900 0183 pse@medtentia.com

Locations
Finland
Helsinki University Hospital, Cardiovascular and Thorax Surgery Clinic Recruiting
Helsinki, Finland, 00029
Principal Investigator: Antti Vento, M.D., PhD         
Sponsors and Collaborators
Medtentia International Ltd Oy
Investigators
Principal Investigator: Kalervo Werkkala, M.D., Prof. Helsinki University Hospital
  More Information

No publications provided

Responsible Party: Medtentia International Ltd Oy
ClinicalTrials.gov Identifier: NCT01678144     History of Changes
Other Study ID Numbers: 2010-040
Study First Received: August 30, 2012
Last Updated: July 3, 2014
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

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

Additional relevant MeSH terms:
Mitral Valve Prolapse
Neurocirculatory Asthenia
Orthostatic Intolerance
Mitral Valve Insufficiency
Anxiety Disorders
Autonomic Nervous System Diseases
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Heart Valve Prolapse
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Primary Dysautonomias
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014