Mitral Heart Valve DiseaseNCT01312779

Magna Mitral - 23mm

A study testing Implantation of CEP Magna Mitral Model 7000TFX in people with Mitral Heart Valve Disease, run by Edwards Lifesciences at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve. Read more about this study

Who is it for?: Ages 13 years and older
Conditions the study is for: Mitral Heart Valve Disease
What is being tested?: Implantation of CEP Magna Mitral Model 7000TFX
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 6 sitesin 2 countries
Study dates: Mar 2011to Nov 2018
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 13 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patient has mitral valve disease requiring surgical replacement
Patient has provided written informed consent prior to mitral valve surgery
Patient is expected to survive surgery and be discharged
Patient is willing to comply with specified follow-up evaluations
Patient is 13 years of age or older

Who cannot join

Patient has life expectancy < 12 months due to non-cardiac co-morbid conditions;
Patient has/had active endocarditis within the last 3 months
Patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve;
Patient was previously enrolled and implanted in the study
Patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ
Patient has a body surface area (BSA) > 1.9m2

Show all 14Show fewer

Female patients who are pregnant, planning to become pregnant, or lactating
Patient has a documented history of substance ( drug or alcohol) abuse
Patient is currently a prison inmate
Patient is currently participating in an investigational drug or another device study
Patient is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
Patient has active myocarditis
Patient has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event and has not returned to baseline or stabilized > 30 days prior to the planned v alve implant surgery
Patient has an abnormality such as an aortic aneurysm (e.g. due to cystic medial necrosis or Marfan's syndrome), aortic dissection, or ventricular aneurysm that might place

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States5 sites

Cooper University Hospital
Camden, New Jersey, 08103
Northwestern Hospital
Chicago, Illinois, 60611
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Florida Hospital
Orlando, Florida, 32803
Washington University
St Louis, Missouri, 63110

Other trials in United States

Poland1 site

The John Paul II Hospital in Krakow
Krakow, 31-202

Other trials in Poland

About this study

Official title: Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX

Read the detailed description

This is a prospective, non-randomized, multi-site, descriptive study. A minimum of 15 and up to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational sites within the US and internationally.

Conditions: Mitral Heart Valve Disease
Being tested: Implantation of CEP Magna Mitral Model 7000TFX
Keywords: Mitral Valve Replacement, 23mm CEP, Magna
Medical subject headings: Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implantation of CEP Magna Mitral Model 7000TFXDevice
Heart valve surgery: CEP Magna Mitral Model 7000 TFX

Study groups in NCT01312779
Study group	Role	What they receive
All subjects receive implant	Other	Subjects serve as own control Receives: Device: Implantation of CEP Magna Mitral Model 7000TFX

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Early Adverse Events Divided
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Measured: Events occuring within 30 days of procedure
Percent of Late Adverse Events
Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Measured: Events occurring >= 31 days and up through 5 years post-implant
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Measured: >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's Average Effective Orifice Area (EOA) Measurement
Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.
Measured: Pre-procedure and 1 Year post-Implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Nov 2018

First posted11 Mar 2011 (estimated)
Study startMar 2011
Primary completionNov 2018
Study completionNov 2018

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.
Other trials for Mitral Heart Valve DiseaseStudies of the same condition, open and under way.
More trials run by Edwards LifesciencesThe sponsor's other registered studies.
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
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01312779
Sponsor's protocol ID: 2008-07
Status last verified: Mar 2020
First submitted: 9 Mar 2011
Last updated: 18 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation

All Mitral Heart Valve Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
ClinicalTrials.gov ID: NCT01312779
Acronym / sponsor ID: 2008-07
Conditions: Mitral Heart Valve Disease
Keywords: Mitral Valve Replacement, 23mm CEP, Magna
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: Mar 2011 (actual)
Primary completion: Nov 2018 (actual)
Study completion: Nov 2018 (actual)
First posted: 11 Mar 2011 (estimated)
Results: Posted 3 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All subjects receive implant	Other	Device: Implantation of CEP Magna Mitral Model 7000TFXSubjects serve as own control

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Patient has mitral valve disease requiring surgical replacement
Patient has provided written informed consent prior to mitral valve surgery
Patient is expected to survive surgery and be discharged
Patient is willing to comply with specified follow-up evaluations
Patient is 13 years of age or older

Key exclusion criteria (14 listed)

Patient has life expectancy < 12 months due to non-cardiac co-morbid conditions;
Patient has/had active endocarditis within the last 3 months
Patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve;
Patient was previously enrolled and implanted in the study
Patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ

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
Implantation of CEP Magna Mitral Model 7000TFXHeart valve surgery: CEP Magna Mitral Model 7000 TFX	Device	All subjects receive implant

Primary outcome

Percent of Early Adverse Events Divided
Time frame: Events occuring within 30 days of procedure
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Percent of Late Adverse Events
Time frame: Events occurring >= 31 days and up through 5 years post-implant
Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
Time frame: >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Subject's Average Effective Orifice Area (EOA) Measurement
Time frame: Pre-procedure and 1 Year post-Implant
Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.

Results and safety

Results posted to the registry on 3 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Magna Mitral 23	39	7

Primary outcome: Percent of Early Adverse Events Divided

Time frame: Events occuring within 30 days of procedure. Number. Unit: percentage of subjects

Measure	Magna Mitral 23 n = 12
Death	8.3
Valve-Related Death	0.0
Thromboembolism	0.0
Valve Thrombosis	0.0
Hemorrhage	0.0
Major Hemorrhage	0.0
Non-Structural Valve Dysfunction (study valve)	8.3
All Clinically Significant PVL	8.3

Population analysed: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Primary outcome: Percent of Late Adverse Events

Time frame: Events occurring >= 31 days and up through 5 years post-implant. Number. Unit: percentage of events/late patient years

Measure	Magna Mitral 23 n = 11
Death	4.5
Valve-Related Death	2.2
Thromboembolism	2.2
Valve Thrombosis	0.0
Hemorrhage	2.2
Major Hemorrhage	2.2
Non-Structural Valve Dysfunction (study valve)	0.0
All Clinically Significant PVL	0.0

Population analysed: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Primary outcome: Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days

Time frame: >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant. Number. Unit: percentage of subjects

Measure	Magna Mitral 23 - >30 Days Post-implant n = 11	Magna Mitral 23 - 1 Year Post-implant n = 11	Magna Mitral 23 - 2 Years Post-implant n = 11	Magna Mitral 23 - 3 Years Post-implant n = 11	Magna Mitral 23 - 4 Years Post-implant n = 11	Magna Mitral 23 - 5 Years Post-implant n = 11
Death	100.00	90.91	90.91	90.91	80.81	80.81
Valve-related Death	100.00	100.0	100.0	100.0	88.89	88.89
Reoperation	100.00	100.00	100.00	100.00	100.00	87.50
Explant	100.00	100.00	100.00	100.00	100.00	87.50
Bleeding Event	100.00	90.00	90.00	90.00	90.00	90.00
Major Bleeding Event	100.00	90.00	90.00	90.00	90.00	90.00
Thromboembolism	100.00	100.00	88.89	88.89	88.89	88.89
Endocarditis	100.00	100.00	100.00	100.00	88.89	88.89

Population analysed: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Primary outcome: Subject's Average Effective Orifice Area (EOA) Measurement

Time frame: Pre-procedure and 1 Year post-Implant. Mean (Standard Deviation). Unit: Centimeters Squared

Measure	Magna Mitral 23 n = 12
Pre-Procedure	0.8 (0.2)
1 Year	1.2 (0.2)

Population analysed: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Adverse events

Time frame: Events occurring from baseline through five years post implant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Magna Mitral 23	12 of 12 (100%)	11 of 12 (91.7%)	3 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
New York Heart Association ClassificationLink provided by the sponsor.

Related trials for Mitral Heart Valve Disease

Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation

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.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of CEP Magna Mitral Model 7000TFX in people with Mitral Heart Valve Disease, run by Edwards Lifesciences at 6 sites in 2 countries.

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 5 inclusion and 14 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: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Poland. 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 3 Mar 2020). 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?

Percent of Early Adverse Events Divided (time frame: Events occuring within 30 days of procedure). The study lists 4 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 NCT01312779.

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 18 Mar 2020.