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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02830204
Other study ID # 016-100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date September 5, 2023

Study information

Verified date January 2024
Source Baylor Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at high-risk for mitral valve surgery or deemed inoperable due to the extent of calcification.


Description:

Technical Success: Alive, with - Successful access, delivery and retrieval of the device delivery system, and - Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and - No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure Device Success: Alive and stroke free, with - Original intended device in place, and - No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/Operating Room(OR)), and - Intended performance of the device: - Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and - Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = Mitral Valve Area (MVA) < 1.5cm2 and Mitral Valve (MV) gradient > 5mmHg, Insufficiency = Mitral Regurgitation (MR) >1+), and - Absence of para-device complications (e.g., Paravalvular Leak (PVL) > mild, need for a Permanent Pacemaker (PPM), erosion, Annular rupture or Aortic Valve (AV) Groove disruption, Left Ventricular Outflow Tract (LVOT) gradient increase > 10mmHg) Procedural Success: Device success, and - No device or procedure related Serious Adverse Events (SAEs) (Life threatening bleed; major vascular or cardiac structural complications requiring unplanned reintervention or surgery; stage 2 or 3 Acute Kidney Injury (includes new dialysis); Myocardial Infarction (MI) or need for percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG); severe heart failure (HF) or hypotension requiring intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support; prolonged intubation ( > 48 hours) 6.2 Secondary objective(s) Device Success (at 6 months and 1 year) - Subject success 1 year Device Success: Alive and stroke free, with - Original intended device in place, and - No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/Operating Room (OR)), and - Intended performance of the device: - Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and - Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA < 1.5cm2 and MV gradient > 5mmHg, Insufficiency = MR >1+), and - Absence of para-device complications (e.g., PVL > mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase > 10mmHg)


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 5, 2023
Est. primary completion date January 3, 2023
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: - Subject has severe native mitral annular calcification associated with mitral stenosis and/or regurgitation. Qualifying echo must be within 60 days of the date of the procedure. - Subject has a clinical indication for mitral valve replacement, as demonstrated by reported New York Heart Association (NYHA) Functional Class II or greater. - The subject is at least 22 years old. - The Heart Team agrees that the subject is high risk or inoperable for surgical mitral valve repair or replacement (MVR), based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. The following concomitant procedures, are allowed: Maze, Tricuspid Valve Procedures (TVP), and Atrial Fibrillation (AF) ablation, coronary artery bypass grafting and septal myectomy. - The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. - The study subject agrees to comply with all required post-procedure follow-up visits Exclusion Criteria: - Evidence of an acute myocardial infarction (MI) = 30 days before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total creatine kinase (CK) elevation of creatine kinase-myocardial band (CK-MB) = twice normal in the presence of myocardial band (MB) elevation and/or troponin level elevation (WHO definition)]. - Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). - Leukopenia (white blood cell count < 2000 cell/mL), acute anemia (hemoglobin < 8 g/dL), or thrombocytopenia (platelet count < 50,000 cell/mL). - Hemodynamic or respiratory instability requiring vasoactive medications, mechanical ventilation at time of procedure. - Need for emergency surgery for any reason. - Severe left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) < 30%. - Severe right ventricular dysfunction - Pregnancy, lactation, or planning to become pregnant - Echocardiographic evidence of left ventricular mass, thrombus, or concerns of active infective endocarditis. - Active upper gastrointestinal (GI) bleeding within 3 months prior to procedure without treatment or 30 days prior to procedure with definitive treatment. - A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be maintained on oral anticoagulant following the study procedure. - End stage renal disease requiring dialysis - Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 30 days of the procedure. - Estimated life expectancy < 12 months

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Mitral Valve Replacement with Sapien3
subjects with surgical MVR with Sapien3

Locations

Country Name City State
United States MHRI Maryland Baltimore Maryland
United States University of Virginia Charlottesville Virginia
United States Baylor College of Medicine Houston Texas
United States St. Vincent Heart Center Indianapolis Indiana
United States The Heart Hospital Baylor Plano Plano Texas
United States Lankenau Institute for Medical Research Wynnewood Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Baylor Research Institute Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Procedural success Procedural Success is defined as:
Device success, and
No device or procedure related serious adverse events (SAEs) (Life threatening bleed; major vascular or cardiac structural complications requiring unplanned reintervention or surgery; stage 2 or 3 acute kidney injury (AKI) (includes new dialysis); myocardial infarction (MI) or need for percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG); severe heart failure (HF) or hypotension requiring intravenous (IV) inotrope, ultrafiltration or mechanical circulatory support; prolonged intubation ( > 48 hours)
30 days
Primary Technical success Technical Success is defined as:
Alive, with
Successful access, delivery and retrieval of the device delivery system, and
Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and
No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure
Procedure Stop Time
Primary Device success Device Success is defined as:
Alive and stroke free, with
Original intended device in place, and
No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/operating room (OR)), and
Intended performance of the device:
Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = mitral valve area (MVA) < 1.5cm2 and mitral valve (MV) gradient > 5mmHg, Insufficiency = mitral regurgitation (MR) >1+), and
Absence of para-device complications (e.g., paravalvular leak (PVL) > mild, need for a permanent pacemaker (PPM), erosion, Annular rupture or aortic valve (AV) Groove disruption, left ventricular outflow tract (LVOT) gradient increase > 10mmHg)
30 days
Secondary Device success Device Success is defined as:
Alive and stroke free, with
Original intended device in place, and
No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/operating room (OR)), and
Intended performance of the device:
Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA < 1.5cm2 and MV gradient > 5mmHg, Insufficiency = MR >1+), and
Absence of para-device complications (e.g., PVL > mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase > 10mmHg)
6 months
Secondary Device Success Device Success is defined as:
Alive and stroke free, with
Original intended device in place, and
No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the cath lab/OR), and
Intended performance of the device:
Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
Hemodynamic performance: Maintenance of relief of stenosis or insufficiency without producing the opposite (Stenosis = MVA < 1.5cm2 and MV gradient > 5mmHg, Insufficiency = MR >1+), and
Absence of para-device complications (e.g., PVL > mild, need for a PPM, erosion, Annular rupture or AV Groove disruption, LVOT gradient increase > 10mmHg)
1 year
Secondary Subject success Subject Success is defined as:
All of the following must be present:
I. Device success (either optimal or acceptable), and II. Patient returned to the pre-procedural setting: and III. No rehospitalizations or reinterventions for the underlying condition (e.g., mitral regurgitation, heart failure); and IV. Improvement from baseline in symptoms (e.g., NYHA improvement by > or = 1 functional class); and V. Improvement from baseline in functional status (e.g., 6-min walk test improvement by > or = 50 m); and VI. Improvement from baseline in quality-of-life (e.g., Kansas City Cardiomyopathy Questionnaire improvement by > or = 10)
1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04429035 - SLOW-Slower Progress of caLcificatiOn With Vitamin K2 N/A
Active, not recruiting NCT03539458 - Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification N/A
Recruiting NCT04408430 - The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves). N/A