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Study on Safety and Performance of Medtentia Annuloplasty Ring in Surgical Repair of Mitral Regurgitation

This study is currently recruiting participants.
Verified March 2013 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: March 12, 2013
Last verified: March 2013
History of Changes
  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 Annuloplasty Ring and Accompanying Accessories When Used in Adults Undergoing Mitral Valve Repair Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtentia International Ltd Oy:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]
    To demonstrate the safety of the MAR and accessories when used during mitral valve repair surgery, in terms of freedom from death at 30 days

  • Procedure success [ Time Frame: During surgery and seven days after the surgery ] [ Designated as safety issue: No ]

    To evaluate the procedural success, including clinical outcome, the following will be assessed:

    • After implantation during surgical procedure no or only residual mitral regurgitation is measured by trans-oesophageal echography (ECHO).
    • An improvement of at least 2 degrees in mitral regurgitation classes (classes I-IV) when comparing screening visit trans-thoracic ECHO and discharge trans-thoracic ECHO (at approx. 7 days).


Secondary Outcome Measures:
  • All cause mortality [ Time Frame: At 3 months, 1 year and 2 years after surgery ] [ Designated as safety issue: Yes ]
  • Occurrence of major adverse cardiac events [ Time Frame: 30 days, 3 months, 1 year and 2 years after surgery ] [ Designated as safety issue: Yes ]
  • Mitral regurgitation [ Time Frame: At screening, at discharge (approx. 7 days) and 3 months after the surgery ] [ Designated as safety issue: No ]

    Will be assessed by measuring:

    • Effective regurgitant orifice area (mm²)
    • Regurgitant volume (mL)
    • Venae contracta (mm)

  • MAR implantation time [ Time Frame: At surgery ] [ Designated as safety issue: No ]
    The MAR implantation time (min), aortic clamp time (min) and time of cardiac arrest (min) will be measured.

  • Mitral valve coaptation height (mm) [ Time Frame: At screening, at discharge (approx. 7 days) and 3 months after the surgery ] [ Designated as safety issue: No ]
  • Left ventricle remodeling (mm) [ Time Frame: At screening, at discharge (approx. 7 days) and 3 months after the surgery ] [ Designated as safety issue: No ]
  • Mitral valve gradient [ Time Frame: At screening, at discharge (approx. 7 days) and 3 months after the surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: June 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent form signed by the subjects.
  • Subjects with indications to undergo mitral valve repair consistent with New York Heart Association (NYHA) functional classification II-IV.
  • 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.
  • Any interventional cardiology procedure within 6 months prior to the study
  • Evidence of acute MI within 30 days of the intended implantation with the investigational device.
  • Prior mitral valve surgery or valvuloplasty or currently implanted prosthetic valve.
  • Restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2.
  • Subjects with fixed pulmonary hypertension.
  • Recent or evolving bacterial endocarditis or subjects under antibiotic therapy.
  • Subjects with implanted cardiac defibrillators (ICDs).
  • Any angiographic or clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device.
  • Subjects who are immunocompromised or with autoimmune diseases.
  • Subjects suffering from renal insufficiency (creatinine >200 mmol/L) or subjects with chronic renal failure undergoing dialysis.
  • 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).
  • History of bleeding diathesis or coagulopathy.
  • Subjects to undergo concomitant cardiac repair or replacement other than CABG (less than or equal to 4 vessels), tricuspid valve repair and ablation therapy for correction of atrial fibrillation.
  • Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease [COPD], hepatic failure, immunosuppressive abnormalities and haematological abnormalities).
  • Significant mitral annular calcification (MAC).
  • Use of Coumadin, IIlb or IIIa inhibitors, Clopidogrel (Plavix) or other anti-coagulants within 5 days prior to surgery.
  • Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device.
  • Intolerance or hypersensitivity to anaesthetics.
  • Subjects in whom trans-oesophageal ECHO/Doppler is contraindicated.
  • Patients who are not suitable for the study based on the surgeons evaluation
  Contacts and Locations
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
  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: March 12, 2013
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013