Magna Mitral

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

NCT00853632

Coronary Artery Disease Mitral Valve Regurgitation Mitral Valve Incompetence +1 more

COMPLETED NA

Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

NCT01171625

Coronary Artery Disease Aortic Valve Disorder Heart Failure +2 more

COMPLETED NA

Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

NCT00705913

Aortic Valve Disease

TERMINATED NA

Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation

NCT04459208

Aortic Valve Stenosis

COMPLETED NA

ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral

NCT06167213

Mitral Regurgitation Mitral Valve Disease Mitral Stenosis

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Heart Valve Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All subjects receive implant

Subjects serve as own control

Group Type OTHER

Implantation of CEP Magna Mitral Model 7000TFX

Intervention Type DEVICE

Heart valve surgery: CEP Magna Mitral Model 7000 TFX

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implantation of CEP Magna Mitral Model 7000TFX

Heart valve surgery: CEP Magna Mitral Model 7000 TFX

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Patient has life expectancy \< 12 months due to non-cardiac co-morbid conditions;
2. Patient has/had active endocarditis within the last 3 months
3. Patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve;
4. Patient was previously enrolled and implanted in the study
5. 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
6. Patient has a body surface area (BSA) \> 1.9m2
7. Female patients who are pregnant, planning to become pregnant, or lactating
8. Patient has a documented history of substance ( drug or alcohol) abuse
9. Patient is currently a prison inmate
10. Patient is currently participating in an investigational drug or another device study
11. Patient is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
12. Patient has active myocarditis
13. 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
14. 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

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No