Mitral RegurgitationNCT01678144
Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
A study testing Mitral valve repair using the Medtentia Annuloplasty Ring (MAR) in people with Mitral Regurgitation and Mitral Insufficiency, run by Medtentia International Ltd Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mitral Regurgitation, Mitral Insufficiency
- What is being tested?
- Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- 30 Jun 2011to 22 Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must meet all the following inclusion criteria:
- 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:
Show all 15Show fewer
- 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.
Who cannot join
- Eligible patients must not meet any of the following exclusion criteria:
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Hospital, Cardiovascular and Thorax Surgery Clinic
Helsinki, 00029
About this study
Official title: Evaluation of the Safety and Performance of the Medtentia Mitral Valve Repair System When Used in Adults Undergoing Mitral Valve Repair Surgery
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.
Read the 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
- Conditions
- Mitral Regurgitation, Mitral Insufficiency
- Being tested
- Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
- Keywords
- mitral valve, mitral surgery, mitral repair, mitral annuloplasty, mitral valve surgery, mitral valve repair, mitral valve annuloplasty
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)Device
| Study group | Role | What they receive |
|---|---|---|
| Medtentia Annuloplasty Ring (MAR) | Experimental | All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR) Receives: Device: Mitral valve repair using the Medtentia Annuloplasty Ring (MAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.
Measured: 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).
Measured: 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.
Mortality rates determined both for all-cause mortality and for related deaths only. For the former, the causality status will be determined by the Investigator, and all deaths that are clearly unrelated to the device, the surgery or the underlying medical condition will be excluded from the analysis.
Measured: 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).
MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.
Measured: 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).
All the adverse events reported were non-device related.
Measured: From surgery to end of study (2 years).
Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).
Measured: 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).
The occurrence, frequency and nature of abnormalities in any of the following:
- physical examination
- vital signs
- electrocardiography (ECG)
- echocardiography (ECHO)
- Laboratory tests
- Chest X-rays (taken only when clinically indicated)
Measured: From surgery to end of study (2 years).
Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.
Success will be defined as no or only residual mitral regurgitation (MR).
Measured: Day of surgery visit (V01).
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).
Measurement analysis at 24 months after successful MAR implantation.
Measured: V06 (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study start30 Jun 2011
- Primary completion30 Jul 2014
- Study completion22 Apr 2016
Why it stopped: Strategic decision by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-national, multi-center, open-label, single-arm
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtentia International Ltd Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kalervo Werkkala, M.D., Prof., Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678144
- Sponsor's protocol ID
- 2010-040
- Status last verified
- Jun 2019
- First submitted
- 30 Aug 2012
- Last updated
- 9 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23566678Jensen 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.
PubMed 22437358
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of the Medtentia Mitral Valve Repair System When Used in Adults Undergoing Mitral Valve Repair Surgery
- ClinicalTrials.gov ID
- NCT01678144
- Acronym / sponsor ID
- 2010-040
- Conditions
- Mitral Regurgitation, Mitral Insufficiency
- Keywords
- mitral valve, mitral surgery, mitral repair, mitral annuloplasty, mitral valve surgery, mitral valve repair, mitral valve annuloplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision by Sponsor
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medtentia International Ltd OyIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2011 (actual)
- Primary completion
- 30 Jul 2014 (actual)
- Study completion
- 22 Apr 2016 (actual)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Posted 9 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-national, multi-center, open-label, single-arm
| Arm | Type | Receives |
|---|---|---|
| Medtentia Annuloplasty Ring (MAR) | Experimental | Device: Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral valve repair using the Medtentia Annuloplasty Ring (MAR) | Device | Medtentia Annuloplasty Ring (MAR) |
Primary outcome
Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.
Time frame: 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).
Time frame: Time from baseline through V03 (3 months)
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).
7 secondary outcomes
Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.
Time frame: 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).
Time frame: 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).
Time frame: From surgery to end of study (2 years).
Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).
Time frame: 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).
Time frame: From surgery to end of study (2 years).
Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.
Time frame: Day of surgery visit (V01).
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).
Time frame: V06 (24 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23566678Konerding 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.
- Background: PubMed 22437358Jensen 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.
- Medtentia Company WebpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalervo Werkkala, M.D., Prof. principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral valve repair using the Medtentia Annuloplasty Ring (MAR) in people with Mitral Regurgitation and Mitral Insufficiency, run by Medtentia International Ltd Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge. (time frame: Time from surgery through hospital discharge, up to 7 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01678144, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.