Clinical trial NCT02520310: AVJ-514 Japan Trial
Official title: A Prospective, Multi-Center, Single-Arm Clinical Evaluation of the AVJ-514 System for the Treatment of Symptomatic Chronic Severe Mitral Regurgitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Stenosis With Insufficiency
Functional Mitral Regurgitation
Mitral Insufficiency
Mitral Valve Incompetence
Mitral Valve Regurgitation
Keywords: Mitral Regurgitation
mitral valve surgery
AVJ-514 Delivery System
Symptomatic Heart Failure
Heart Valve Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart team.

Detailed description: This study is a prospective, multi-center, single-arm clinical evaluation of the AVJ-514 System for the treatment of symptomatic chronic severe mitral regurgitation (MR) in Japanese subjects deemed difficult for mitral valve surgery by the local site heart team.

Patients will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years in Japanese Medical Centers.

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria:

1. Age 20 years or older.
2. Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic Degenerative Mitral Regurgitation (DMR) or Functional Mitral Regurgitation (FMR) determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within180 days prior to subject registration, with MR severity based principally on the TTE study and confirmed by the Echocardiography Core Laboratory (ECL). The ECL may request a TEE.
3. Left Ventricular Ejection Fraction (LVEF) is ≥ 30％ within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment).
4. New York Heart Association (NYHA) classification is class II, class III, or ambulatory class IV.
5. Subject is deemed difficult for mitral valve surgery due to either Society of Thoracic Surgery (STS) surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors:

   * Porcelain aorta or mobile ascending aortic atheroma
   * Post-radiation mediastinum
   * Previous mediastinitis
   * Functional MR with LVEF \< 40%
   * Over 75 years old with LVEF \< 40%
   * Re-operation with patent grafts
   * Two or more prior cardiothoracic surgeries
   * Hepatic cirrhosis
   * Other surgical risk factor(s)
6. Mitral valve area ≥ 4.0 cm2 assessed by ECL based TTE within 90 days prior to subject registration. The ECL may request a TEE.
7. Left Ventricular End Systolic Dimension (LVESD) is ≤ 60mm assessed by site based on the TTE obtained within 90 days prior to subject registration.
8. The primary regurgitant jet is non-commissural based on TEE, and in the opinion of the AVJ-514 implanting investigator can successfully be treated by the AVJ-514. If a secondary jet exists, it must be considered clinically insignificant.
9. Transseptal catheterization and femoral vein access is determined to be feasible by the treating physician.
10. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.

Exclusion Criteria:

Subjects must not meet any of the following exclusion criteria:

1. LVEF is \< 30%
2. Leaflet anatomy which may preclude AVJ-514 implantation, proper positioning on the leaflets or sufficient reduction in MR by the AVJ-514 based. This evaluation is based on TEE evaluation of the mitral valve within 180 days prior to subject registration and includes:

   * Insufficient mobile leaflet available for grasping with the AVJ-514 device
   * Lack of both primary and secondary chordal support in the grasping area
   * Evidence of significant calcification in the grasping area
   * Presence of a significant cleft in the grasping area
3. Life expectancy \< 1 year due to associated non-cardiac co-morbid conditions
4. Need for emergent or urgent surgery for any reason
5. Prior open heart mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure.
6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
7. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated).
8. Untreated clinically significant coronary artery disease requiring revascularization or significant myocardial ischemia or evidence of an acute myocardial infarction in the prior 90 days of registration.
9. Cerebrovascular accident within 180 days prior to registration
10. Severe symptomatic carotid stenosis (\> 70% by ultrasound)
11. Any cardiac surgery within 180 days prior to registration
12. Percutaneous coronary intervention (PCI) within the last 30 days prior to registration
13. Implant of Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy with Cardioverter Defibrillator (CRT-D) pacemaker or Implantable Cardioverter Defibrillator (ICD)within the last 30 days prior to registration.
14. Transcatheter aortic valve replacement (TAVR) within the last 30 days prior to registration.
15. Severe tricuspid regurgitation or aortic valve disease requiring surgical treatment.
16. In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).
17. Hemodynamic instability defined as systolic pressure \< 90 mmHg without afterload reduction drug or cardiogenic shock or intra-aortic balloon pump.
18. History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
19. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll at least 14 days after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 21 days prior to treatment.
20. Intravenous drug abuse or suspected inability to adhere to follow-up.
21. Patients in whom TEE is contraindicated.
22. A known hypersensitivity or contraindication to study or procedure medications which cannot be adequately managed medically.
23. In the judgment of the Investigator, subjects in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads.
24. Subject intends to participate in any other investigational or invasive clinical study within a period of 1 year following the AVJ-514 procedure.
25. Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
26. In the opinion of the investigator or designee, subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
27. In the opinion of the anesthesiologist, general anesthesia is contraindicated.
28. Pregnant or planning pregnancy within next 1 year.

Primary outcomes:
measure: Number of Participants With Acute Procedure Success (APS)
timeFrame: On day 0 (the day of procedure)
Secondary outcomes:
measure: Percentage of Participants With Major Adverse Events (MAE) at 30 Days
timeFrame: 30 days
measure: Percentage of Participants With MAE at 1 Year
timeFrame: 1 year
measure: Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access
timeFrame: 30 days
measure: Number of Participants With Mitral Valve Stenosis Requiring Surgery
timeFrame: 1 year
measure: Number of Participants With Mitral Valve Stenosis Not Requiring Surgery
timeFrame: 1 year
measure: Number of Participants With Single Leaflet Device Attachment (SLDA) Requiring Surgery
timeFrame: 1 year
measure: Number of Participants With Single Leaflet Device Attachment (SLDA) Not Requiring Surgery
timeFrame: 1 year
measure: Number of Participants With Iatrogenic Atrial Septal Defect
timeFrame: 30 days
measure: Percentage of Participants With Device Implant Rate
timeFrame: On the day of procedure
measure: Device Procedure Time
timeFrame: On the day of procedure
measure: Total Procedure Time
timeFrame: On the day of procedure
measure: Device Time
timeFrame: On the day of procedure
measure: Fluoroscopy Duration
timeFrame: On the day of procedure
measure: Length of Stay in Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-Anesthesia Care Unit (PACU) (ICU/CCU/PACU)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Length of Hospital Stay Excluding Rehabilitation Stay
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Length of Rehabilitation Stay
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Percentage of Participants With Discharge Status
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Length of Stay (Not at Baseline Facility)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Number of Participants With Mitral Regurgitation (MR) Severity Grade
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Number of Participants With MR Severity Grade
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Number of Participants With MR Severity Grade
timeFrame: 30 days
measure: Number of Participants With MR Severity Grade
timeFrame: 6 months
measure: Number of Participants With MR Severity Grade
timeFrame: 1 year
measure: MR Severity Grade
timeFrame: 24 months
measure: MR Severity Grade
timeFrame: 3 years
measure: MR Severity Grade
timeFrame: 4 years
measure: MR Severity Grade
timeFrame: 5 years
measure: Regurgitant Volume (RV)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Regurgitant Volume (RV)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Regurgitant Volume (RV)
timeFrame: 30 days
measure: Regurgitant Volume (RV)
timeFrame: 6 months
measure: Regurgitant Volume (RV)
timeFrame: 1 year
measure: Regurgitant Volume (RV)
timeFrame: 24 months
measure: Regurgitant Volume (RV)
timeFrame: 3 years
measure: Regurgitant Volume (RV)
timeFrame: 4 years
measure: Regurgitant Volume (RV)
timeFrame: 5 years
measure: Regurgitant Fraction (RF)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Regurgitant Fraction (RF)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Regurgitant Fraction (RF)
timeFrame: 30 days
measure: Regurgitant Fraction (RF)
timeFrame: 6 months
measure: Regurgitant Fraction (RF)
timeFrame: 1 year
measure: Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 30 days
measure: Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 6 months
measure: Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 1 year
measure: Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 24 months
measure: Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 3 years
measure: Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 4 years
measure: Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: 5 years
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 30 days
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 6 months
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 1 year
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 24 months
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 3 years
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 4 years
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: 5 years
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 30 days
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 6 months
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 1 year
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 24 months
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 3 years
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 4 years
measure: Left Ventricular End Diastolic Dimension (LVEDD)
timeFrame: 5 years
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 30 days
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 6 months
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 1 year
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 24 months
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 3 years
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 4 years
measure: Left Ventricular End Systolic Dimension (LVESD)
timeFrame: 5 years
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 30 days
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 6 months
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 1 year
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 24 months
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 3 years
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 4 years
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 5 years
measure: Pulmonary Artery Systolic Pressure (PASP)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Pulmonary Artery Systolic Pressure (PASP)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Pulmonary Artery Systolic Pressure (PASP)
timeFrame: 30 days
measure: Pulmonary Artery Systolic Pressure (PASP)
timeFrame: 6 months
measure: Pulmonary Artery Systolic Pressure (PASP)
timeFrame: 1 year
measure: Pulmonary Artery Systolic Pressure (PASP)
timeFrame: 24 months
measure: Pulmonary Artery Systolic Pressure (PASP)
timeFrame: 3 years
measure: Pulmonary Artery Systolic Pressure (PASP)
timeFrame: 4 years
measure: Pulmonary Artery Systolic Pressure (PASP)
timeFrame: 5 years
measure: Mitral Valve Area (MVA)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Mitral Valve Area (MVA)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Mitral Valve Area (MVA)
timeFrame: 30 days
measure: Mitral Valve Area(MVA)
timeFrame: 6 months
measure: Mitral Valve Area(MVA)
timeFrame: 1 year
measure: Mitral Valve Area (MVA)
timeFrame: 24 months
measure: Mitral Valve Area (MVA)
timeFrame: 3 years
measure: Mitral Valve Area (MVA)
timeFrame: 4 years
measure: Mitral Valve Area (MVA)
timeFrame: 5 years
measure: Mean Mitral Valve Pressure Gradient (MVG)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Mean Mitral Valve Pressure Gradient (MVG)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Mean Mitral Valve Pressure Gradient (MVG)
timeFrame: 30 days
measure: Mean Mitral Valve Pressure Gradient (MVG)
timeFrame: 6 months
measure: Mean Mitral Valve Pressure Gradient (MVG)
timeFrame: 1 year
measure: Mean Mitral Valve Pressure Gradient (MVG)
timeFrame: 24 months
measure: Mean Mitral Valve Pressure Gradient (MVG)
timeFrame: 3 years
measure: Mean Mitral Valve Pressure Gradient (MVG)
timeFrame: 4 years
measure: Mean Mitral Valve Pressure Gradient (MVG)
timeFrame: 5 years
measure: Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 30 days
measure: Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 6 months
measure: Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 1 year
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 24 months
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 3 years
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 4 years
measure: Systolic Anterior Motion of the Mitral Valve (Present or Absent)
timeFrame: 5 years
measure: Forward Stroke Volume (FSV)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Forward Stroke Volume (FSV)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Forward Stroke Volume (FSV)
timeFrame: 30 days
measure: Forward Stroke Volume (FSV)
timeFrame: 6 months
measure: Forward Stroke Volume (FSV)
timeFrame: 1 year
measure: Forward Stroke Volume (FSV)
timeFrame: 24 months
measure: Forward Stroke Volume (FSV)
timeFrame: 3 years
measure: Forward Stroke Volume (FSV)
timeFrame: 4 years
measure: Forward Stroke Volume (FSV)
timeFrame: 5 years
measure: Cardiac Output (CO)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Cardiac Output (CO)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Cardiac Output (CO)
timeFrame: 30 days
measure: Cardiac Output (CO)
timeFrame: 6 months
measure: Cardiac Output (CO)
timeFrame: 1 year
measure: Cardiac Output (CO)
timeFrame: 24 months
measure: Cardiac Output (CO)
timeFrame: 3 years
measure: Cardiac Output (CO)
timeFrame: 4 years
measure: Cardiac Output (CO)
timeFrame: 5 years
measure: Cardiac Index (CI)
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Cardiac Index (CI)
timeFrame: At Discharge (≤ 14.4 ± 8.5 days post index procedure)
measure: Cardiac Index (CI)
timeFrame: 30 days
measure: Cardiac Index (CI)
timeFrame: 6 months
measure: Cardiac Index (CI)
timeFrame: 1 year
measure: Cardiac Index (CI)
timeFrame: 24 months
measure: Cardiac Index (CI)
timeFrame: 3 years
measure: Cardiac Index (CI)
timeFrame: 4 years
measure: Cardiac Index (CI)
timeFrame: 5 years
measure: Number of Participants With All-cause Mortality
timeFrame: 1 year
measure: All-cause Mortality
timeFrame: 24 months
measure: All-cause Mortality
timeFrame: 3 years
measure: All-cause Mortality
timeFrame: 4 years
measure: All-cause Mortality
timeFrame: 5 years
measure: Number of Participants With the Primary Safety Composite of MAE at 1 Year
timeFrame: 12 months
measure: Freedom From the Components of the Primary Safety Composite of MAE
timeFrame: 24 months
measure: Freedom From the Components of the Primary Safety Composite of MAE
timeFrame: 3 years
measure: Freedom From the Components of the Primary Safety Composite of MAE
timeFrame: 4 years
measure: Freedom From the Components of the Primary Safety Composite of MAE
timeFrame: 5 years
measure: Number of Patients With New York Heart Association (NYHA) Functional Class
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Number of Participants With NYHA Functional Class
timeFrame: 30 days
measure: Number of Participants With NYHA Functional Class
timeFrame: 6 months
measure: Number of Participants With NYHA Functional Class
timeFrame: 1 year
measure: NYHA Functional Class
timeFrame: 24 months
measure: NYHA Functional Class
timeFrame: 3 years
measure: NYHA Functional Class
timeFrame: 4 years
measure: NYHA Functional Class
timeFrame: 5 years
measure: Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) Scores
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: KCCQ QoL Scores
timeFrame: 30 days
measure: KCCQ QoL Scores
timeFrame: 6 months
measure: KCCQ QoL Scores
timeFrame: 1 year
measure: Change in KCCQ QoL Scores From Baseline to 1 Year
timeFrame: Baseline to 1 Year
measure: KCCQ QoL Scores
timeFrame: 24 months
measure: KCCQ QoL Scores
timeFrame: 3 years
measure: KCCQ QoL Scores
timeFrame: 4 years
measure: KCCQ QoL Scores
timeFrame: 5 years
measure: SF-36 QoL Scores
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: SF-36 QoL Scores
timeFrame: 30 days
measure: SF-36 QoL Scores
timeFrame: 6 months
measure: SF-36 QoL Scores
timeFrame: 1 year
measure: Change in SF-36 QoL Scores From Baseline to 1 Year
timeFrame: From baseline to 1 year
measure: SF-36 QoL Scores
timeFrame: 24 months
measure: Change in SF-36 QoL Scores From Baseline
timeFrame: At 24 months
measure: Number of Participants Undergoing Mitral Valve Surgery
timeFrame: Through 5 years
measure: Number of Participants With Additional Mitra Clip Device Intervention
timeFrame: Through 5 years
measure: Six Minute Walk Test (6MWT) Distance
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Six Minute Walk Test (6MWT) Distance
timeFrame: 6 months
measure: Six Minute Walk Test (6MWT) Distance
timeFrame: 1 year
measure: Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year
timeFrame: Baseline to 1 year
measure: Six Minute Walk Test (6MWT) Distance
timeFrame: 24 months
measure: Changes in Six Minute Walk Test (6MWT) Distance From Baseline
timeFrame: At 24 months
measure: Six Minute Walk Test (6MWT) Distance
timeFrame: 3 years
measure: Six Minute Walk Test (6MWT) Distance
timeFrame: 4 years
measure: Six Minute Walk Test (6MWT) Distance
timeFrame: 5 years
measure: Number of Participants With Mitral Valve Surgery
timeFrame: 30 days
measure: Number of Participants With Mitral Valve Surgery
timeFrame: 1 year
measure: Number of Participants With Additional AVJ-514 Device Intervention
timeFrame: 30 days
measure: Number of Participants With Additional AVJ-514 Device Intervention
timeFrame: 1 year
measure: Number of Hospitalizations and Reason for Hospitalization
timeFrame: 1 year post index procedure
measure: Number of Hospitalizations
timeFrame: 24 months
measure: Number of Hospitalizations
timeFrame: 3 years
measure: Number of Hospitalizations
timeFrame: 4 years
measure: Number of Hospitalizations
timeFrame: 5 years
measure: Number of Participants With Mitral Stenosis
timeFrame: 1 year
measure: Mitral Stenosis
timeFrame: 24 months
measure: Mitral Stenosis
timeFrame: 3 years
measure: Mitral Stenosis
timeFrame: 4 years
measure: Mitral Stenosis
timeFrame: 5 years
measure: Number of Participants With Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
timeFrame: 12 months
measure: Number of Participants With Clinically Significant ASD That Requires Intervention
timeFrame: 24 months
measure: Number of Participants With Clinically Significant ASD That Requires Intervention
timeFrame: 3 years
measure: Number of Participants With Clinically Significant ASD That Requires Intervention
timeFrame: 4 years
measure: Number of Participants With Clinically Significant ASD That Requires Intervention
timeFrame: 5 years
measure: Number of Participants With Major Bleeding
timeFrame: 30 days
measure: Number of Participants With Major Bleeding
timeFrame: 1 year
measure: Number of Participants With Usage of Concomitant Cardiac Medications
timeFrame: At baseline (Within 14 days prior to the AVJ-514 procedure)
measure: Number of Participants With Usage of Concomitant Cardiac Medications
timeFrame: 30 days
measure: Number of Participants With Usage of Concomitant Cardiac Medications
timeFrame: 6 months
measure: Number of Participants With Usage of Concomitant Cardiac Medications
timeFrame: 1 year
measure: Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior
timeFrame: 1 Year Pre and Post Index Procedure
measure: Number of Participants With Device Embolization Requiring Surgery
timeFrame: 1 year
measure: Number of Participants With Device Embolization Not Requiring Surgery
timeFrame: 1 year
measure: Regurgitant Fraction (RF)
timeFrame: 2 year
measure: Regurgitant Fraction (RF)
timeFrame: 3 year
measure: Regurgitant Fraction (RF)
timeFrame: 4 year
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: Shonan Kamakura General Hospital
city: Miyagi
country: Japan
facility: Sendai Kosei Hospital
city: Osaka
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Sakakibara Heart Institute
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
Study officials:
affiliation: Keio University
name: Ryohei Yozu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakakibara Heart Institute
name: Morimasa Takayama, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott Vascular, Inc.
name: Peter Staehr, MD
role: STUDY_DIRECTOR
References:
citation: Hayashida K, Yasuda S, Matsumoto T, Amaki M, Mizuno S, Tobaru T, Jujo K, Ootomo T, Yamaguchi J, Fukuda K, Saito S, Foster E, Qasim A, Kitakaze M, Yozu R, Takayama M. AVJ-514 Trial - Baseline Characteristics and 30-Day Outcomes Following MitraClip(R) Treatment in a Japanese Cohort. Circ J. 2017 Jul 25;81(8):1116-1122. doi: 10.1253/circj.CJ-17-0115. Epub 2017 Mar 17.