Brief Summary
The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.
Brief Title
Abbott Cephea Mitral Valve Disease Registry
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1+612.816.4605
Central Contact Email
cepheamvdregistry@abbott.com
Completion Date
Completion Date Type
Estimated
Conditions
Mitral Regurgitation
Mitral Stenosis
Mitral Valve Disease
Mitral Valve (MV) Regurgitation
Mitral Annulus Calcification
Mitral Valve Replacement
Transcatheter Valve Replacement
Eligibility Criteria
Inclusion Criteria:
1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.
4. Age 18 years or older at time of consent.
5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.
Exclusion Criteria:
1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
2. Subject is undergoing dialysis or experiencing chronic renal failure
3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use
4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.
5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.
1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.
4. Age 18 years or older at time of consent.
5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.
Exclusion Criteria:
1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
2. Subject is undergoing dialysis or experiencing chronic renal failure
3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use
4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.
5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.
Inclusion Criteria
Inclusion Criteria:
1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.
4. Age 18 years or older at time of consent.
5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.
1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.
4. Age 18 years or older at time of consent.
5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.
Gender
All
Gender Based
false
Keywords
Mitral Valve Disease
registry
Cephea Mitral Valve System
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07069673
Org Class
Industry
Org Full Name
Abbott Medical Devices
Org Study Id
ABT-CIP-10593
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Abbott Cephea Mitral Valve Disease Registry
Primary Outcomes
Outcome Description
The objective of the MVD Registry is to collect data on the progression of MVD patients considered for TMVR therapy to guide product development, regulatory submissions, and reimbursement planning
Outcome Measure
Primary Objective
Outcome Time Frame
From enrollment to 2 years of follow-up
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
This registry will enroll subjects over 18 years of age of all genders with symptomatic mitral valve disease including those with mitral regurgitation, mitral stenosis, and mixed mitral valve disease, who are candidates for transcatheter mitral valve replacement.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andrea Scotti
Investigator Email
ascotti@montefiore.org
Investigator Department
Medicine
Investigator Division
Cardiology
Investigator Sponsor Organization
Montefiore
Study Department
Medicine
Study Division
Cardiology
Categories Mesh Debug
Heart/Cardiovascular --- HEART VALVE DISEASES
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
MeSH Terms
MITRAL VALVE INSUFFICIENCY
MITRAL VALVE STENOSIS
GASTROESOPHAGEAL REFLUX
HEART VALVE DISEASES
HEART DISEASES
CARDIOVASCULAR DISEASES
ESOPHAGEAL MOTILITY DISORDERS
DEGLUTITION DISORDERS
ESOPHAGEAL DISEASES
GASTROINTESTINAL DISEASES
DIGESTIVE SYSTEM DISEASES