Overview

This trial is active, not recruiting.

Conditions mitral stenosis with insufficiency, functional mitral regurgitation, mitral insufficiency, mitral valve incompetence, mitral valve regurgitation
Treatment avj-514
Sponsor Abbott Vascular
Start date August 2015
End date July 2016
Trial size 30 participants
Trial identifier NCT02520310, AVJ-514

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The AVJ-514 system
avj-514
Patients receiving AVJ-514 device

Primary Outcomes

Measure
Primary safety composite as measured by freedom from Major Adverse Events (MAE)
time frame: 30 days
Primary efficacy as measured by Acute Procedure Success (APS)
time frame: At discharge or at 30 days

Secondary Outcomes

Measure
All-cause mortality
time frame: 12 months
All-cause mortality
time frame: 24 months
All-cause mortality
time frame: 3 years
All-cause mortality
time frame: 4 years
All-cause mortality
time frame: 5 years
Freedom from the components of the primary safety composite of MAE
time frame: 12 months
Freedom from the components of the primary safety composite of MAE
time frame: 24 months
Freedom from the components of the primary safety composite of MAE
time frame: 3 years
Freedom from the components of the primary safety composite of MAE
time frame: 4 years
Freedom from the components of the primary safety composite of MAE
time frame: 5 years
Primary safety composite as measured by freedom from MAE
time frame: 12 months
Primary safety composite as measured by freedom from MAE
time frame: 24 months
Primary safety composite as measured by freedom from MAE
time frame: 3 years
Primary safety composite as measured by freedom from MAE
time frame: 4 years
Primary safety composite as measured by freedom from MAE
time frame: 5 years
New York Heart Association (NHYA) Functional Class
time frame: At baseline
NHYA Functional Class
time frame: 30 days
NHYA Functional Class
time frame: 6 months
NHYA Functional Class
time frame: 12 months
NHYA Functional Class
time frame: 24 months
NHYA Functional Class
time frame: 3 years
NHYA Functional Class
time frame: 4 years
NHYA Functional Class
time frame: 5 years
Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) scores
time frame: At baseline
KCCQ QoL scores
time frame: 30 days
KCCQ QoL scores
time frame: 6 months
KCCQ QoL scores
time frame: 12 months
KCCQ QoL scores
time frame: 24 months
KCCQ QoL scores
time frame: 3 years
KCCQ QoL scores
time frame: 4 years
KCCQ QoL scores
time frame: 5 years
SF-36 QoL scores
time frame: At baseline
SF-36 QoL scores
time frame: 30 days
SF-36 QoL scores
time frame: 6 months
SF-36 QoL scores
time frame: 12 months
SF-36 QoL scores
time frame: 24 months
Change in SF-36 QoL scores from baseline
time frame: At 30 days
Change in SF-36 QoL scores from baseline
time frame: At 12 months
Change in SF-36 QoL scores from baseline
time frame: At 24 months
Six Minute Walk Test (6MWT) distance
time frame: At baseline
Six Minute Walk Test (6MWT) distance
time frame: 6 months
Six Minute Walk Test (6MWT) distance
time frame: 12 months
Six Minute Walk Test (6MWT) distance
time frame: 24 months
Six Minute Walk Test (6MWT) distance
time frame: 3 years
Six Minute Walk Test (6MWT) distance
time frame: 4 years
Six Minute Walk Test (6MWT) distance
time frame: 5 years
Changes in Six Minute Walk Test (6MWT) distance from baseline
time frame: At 30 days
Changes in Six Minute Walk Test (6MWT) distance from baseline
time frame: At 6 months
Changes in Six Minute Walk Test (6MWT) distance from baseline
time frame: At 12 months
Changes in Six Minute Walk Test (6MWT) distance from baseline
time frame: At 24 months
Number of participants undergoing mitral valve surgery
time frame: Through 5 years
Number of participants with additional MitraClip device intervention
time frame: Through 5 years
Number of hospitalizations
time frame: 12 months
Number of hospitalizations
time frame: 24 months
Number of hospitalizations
time frame: 3 years
Number of hospitalizations
time frame: 4 years
Number of hospitalizations
time frame: 5 years
Mitral stenosis
time frame: 12 months
Mitral stenosis
time frame: 24 months
Mitral stenosis
time frame: 3 years
Mitral stenosis
time frame: 4 years
Mitral stenosis
time frame: 5 years
Number of participants with clinically significant atrial septal defect (ASD) that requires intervention
time frame: 12 months
Number of participants with clinically significant ASD that requires intervention
time frame: 24 months
Number of participants with clinically significant ASD that requires intervention
time frame: 3 years
Number of participants with clinically significant ASD that requires intervention
time frame: 4 years
Number of participants with clinically significant ASD that requires intervention
time frame: 5 years
Number of participants with device-related complications
time frame: Through 5 years
Major bleeding
time frame: 30 days
Usage of concomitant cardiac medications
time frame: At baseline
Change in concomitant cardiac medications
time frame: 30 days
Change in concomitant cardiac medications
time frame: 6 months
Change in concomitant cardiac medications
time frame: 12 months
Rate of heart failure hospitalizations
time frame: 1 year post-AVJ-514 procedure vs. 12 months prior
MAE occurring after the femoral vein puncture for transseptal access
time frame: 30 days
Device Implant Rate
time frame: On the day of procedure
Device Procedure Time
time frame: On the day of procedure
Total Procedure Time
time frame: On the day of procedure
Device Time
time frame: On the day of procedure
Fluoroscopy duration
time frame: On the day of procedure
Length of stay in Intensive Care Unit/Critical Care Unit/Post-Anesthesia Care Unit (ICU/CCU/PACU)
time frame: From the day of procedure through 30 days
Length of hospital stay excluding rehabilitation stay
time frame: From the day of procedure through 30 days
Length of rehabilitation stay
time frame: From the day of procedure through 30 days
Length of stay at facility to which the subject was discharged
time frame: From the day of procedure through 30 days
Mitral Regurgitation (MR) Severity Grade
time frame: At baseline
MR Severity Grade
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
MR Severity Grade
time frame: 30 days
MR Severity Grade
time frame: 6 months
MR Severity Grade
time frame: 12 months
MR Severity Grade
time frame: 24 months
MR Severity Grade
time frame: 3 years
MR Severity Grade
time frame: 4 years
MR Severity Grade
time frame: 5 years
Effective Regurgitant Orifice Area
time frame: At baseline
Effective Regurgitant Orifice Area
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Effective Regurgitant Orifice Area
time frame: 30 days
Effective Regurgitant Orifice Area
time frame: 6 months
Effective Regurgitant Orifice Area
time frame: 12 months
Effective Regurgitant Orifice Area
time frame: 24 months
Effective Regurgitant Orifice Area
time frame: 3 years
Effective Regurgitant Orifice Area
time frame: 4 years
Effective Regurgitant Orifice Area
time frame: 5 years
Regurgitant Volume (RV)
time frame: At baseline
Regurgitant Volume (RV)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Regurgitant Volume (RV)
time frame: 30 days
Regurgitant Volume (RV)
time frame: 6 months
Regurgitant Volume (RV)
time frame: 12 months
Regurgitant Volume (RV)
time frame: 24 months
Regurgitant Volume (RV)
time frame: 3 years
Regurgitant Volume (RV)
time frame: 4 years
Regurgitant Volume (RV)
time frame: 5 years
Left Ventricular End Diastolic Volume (LVEDV)
time frame: At baseline
Left Ventricular End Diastolic Volume (LVEDV)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Left Ventricular End Diastolic Volume (LVEDV)
time frame: 30 days
Left Ventricular End Diastolic Volume (LVEDV)
time frame: 6 months
Left Ventricular End Diastolic Volume (LVEDV)
time frame: 12 months
Left Ventricular End Diastolic Volume (LVEDV)
time frame: 24 months
Left Ventricular End Diastolic Volume (LVEDV)
time frame: 3 years
Left Ventricular End Diastolic Volume (LVEDV)
time frame: 4 years
Left Ventricular End Diastolic Volume (LVEDV)
time frame: 5 years
Left Ventricular End Systolic Volume (LVESV)
time frame: At baseline
Left Ventricular End Systolic Volume (LVESV)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Left Ventricular End Systolic Volume (LVESV)
time frame: 30 days
Left Ventricular End Systolic Volume (LVESV)
time frame: 6 months
Left Ventricular End Systolic Volume (LVESV)
time frame: 12 months
Left Ventricular End Systolic Volume (LVESV)
time frame: 24 months
Left Ventricular End Systolic Volume (LVESV)
time frame: 3 years
Left Ventricular End Systolic Volume (LVESV)
time frame: 4 years
Left Ventricular End Systolic Volume (LVESV)
time frame: 5 years
Left Ventricular End Diastolic Dimension (LVEDD)
time frame: At baseline
Left Ventricular End Diastolic Dimension (LVEDD)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Left Ventricular End Diastolic Dimension (LVEDD)
time frame: 30 days
Left Ventricular End Diastolic Dimension (LVEDD)
time frame: 6 months
Left Ventricular End Diastolic Dimension (LVEDD)
time frame: 12 months
Left Ventricular End Diastolic Dimension (LVEDD)
time frame: 24 months
Left Ventricular End Diastolic Dimension (LVEDD)
time frame: 3 years
Left Ventricular End Diastolic Dimension (LVEDD)
time frame: 4 years
Left Ventricular End Diastolic Dimension (LVEDD)
time frame: 5 years
Left Ventricular End Systolic Dimension (LVESD)
time frame: At baseline
Left Ventricular End Systolic Dimension (LVESD)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Left Ventricular End Systolic Dimension (LVESD)
time frame: 30 days
Left Ventricular End Systolic Dimension (LVESD)
time frame: 6 months
Left Ventricular End Systolic Dimension (LVESD)
time frame: 12 months
Left Ventricular End Systolic Dimension (LVESD)
time frame: 24 months
Left Ventricular End Systolic Dimension (LVESD)
time frame: 3 years
Left Ventricular End Systolic Dimension (LVESD)
time frame: 4 years
Left Ventricular End Systolic Dimension (LVESD)
time frame: 5 years
Left Ventricular Ejection Fraction (LVEF)
time frame: At baseline
Left Ventricular Ejection Fraction (LVEF)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Left Ventricular Ejection Fraction (LVEF)
time frame: 30 days
Left Ventricular Ejection Fraction (LVEF)
time frame: 6 months
Left Ventricular Ejection Fraction (LVEF)
time frame: 12 months
Left Ventricular Ejection Fraction (LVEF)
time frame: 24 months
Left Ventricular Ejection Fraction (LVEF)
time frame: 3 years
Left Ventricular Ejection Fraction (LVEF)
time frame: 4 years
Left Ventricular Ejection Fraction (LVEF)
time frame: 5 years
Right Ventricular Systolic Pressure (RVSP)
time frame: At baseline
Right Ventricular Systolic Pressure (RVSP)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Right Ventricular Systolic Pressure (RVSP)
time frame: 30 days
Right Ventricular Systolic Pressure (RVSP)
time frame: 6 months
Right Ventricular Systolic Pressure (RVSP)
time frame: 12 months
Right Ventricular Systolic Pressure (RVSP)
time frame: 24 months
Right Ventricular Systolic Pressure (RVSP)
time frame: 3 years
Right Ventricular Systolic Pressure (RVSP)
time frame: 4 years
Right Ventricular Systolic Pressure (RVSP)
time frame: 5 years
Mitral Valve Area(MVA)
time frame: At baseline
Mitral Valve Area (MVA)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Mitral Valve Area (MVA)
time frame: 30 days
Mitral Valve Area (MVA)
time frame: 6 months
Mitral Valve Area (MVA)
time frame: 12 months
Mitral Valve Area (MVA)
time frame: 24 months
Mitral Valve Area (MVA)
time frame: 3 years
Mitral Valve Area (MVA)
time frame: 4 years
Mitral Valve Area (MVA)
time frame: 5 years
Mean Mitral Valve Pressure Gradient (MVG)
time frame: At baseline
Mean Mitral Valve Pressure Gradient (MVG)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Mean Mitral Valve Pressure Gradient (MVG)
time frame: 30 days
Mean Mitral Valve Pressure Gradient (MVG)
time frame: 6 months
Mean Mitral Valve Pressure Gradient (MVG)
time frame: 12 months
Mean Mitral Valve Pressure Gradient (MVG)
time frame: 24 months
Mean Mitral Valve Pressure Gradient (MVG)
time frame: 3 years
Mean Mitral Valve Pressure Gradient (MVG)
time frame: 4 years
Mean Mitral Valve Pressure Gradient (MVG)
time frame: 5 years
Systolic Anterior Motion of the mitral valve (present or absent)
time frame: At baseline
Systolic Anterior Motion of the mitral valve (present or absent)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Systolic Anterior Motion of the mitral valve (present or absent)
time frame: 30 days
Systolic Anterior Motion of the mitral valve (present or absent)
time frame: 6 months
Systolic Anterior Motion of the mitral valve (present or absent)
time frame: 12 months
Systolic Anterior Motion of the mitral valve (present or absent)
time frame: 24 months
Systolic Anterior Motion of the mitral valve (present or absent)
time frame: 3 years
Systolic Anterior Motion of the mitral valve (present or absent)
time frame: 4 years
Systolic Anterior Motion of the mitral valve (present or absent)
time frame: 5 years
Forward Stroke Volume (FSV)
time frame: At baseline
Forward Stroke Volume (FSV)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Forward Stroke Volume (FSV)
time frame: 30 days
Forward Stroke Volume (FSV)
time frame: 6 months
Forward Stroke Volume (FSV)
time frame: 12 months
Forward Stroke Volume (FSV)
time frame: 24 months
Forward Stroke Volume (FSV)
time frame: 3 years
Forward Stroke Volume (FSV)
time frame: 4 years
Forward Stroke Volume (FSV)
time frame: 5 years
Cardiac Output (CO)
time frame: At baseline
Cardiac Output (CO)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Cardiac Output (CO)
time frame: 30 days
Cardiac Output (CO)
time frame: 6 months
Cardiac Output (CO)
time frame: 12 months
Cardiac Output (CO)
time frame: 24 months
Cardiac Output (CO)
time frame: 3 years
Cardiac Output (CO)
time frame: 4 years
Cardiac Output (CO)
time frame: 5 years
Cardiac Index (CI)
time frame: At baseline
Cardiac Index (CI)
time frame: Participants will be followed-up at discharge, an expected duration within 30 days
Cardiac Index (CI)
time frame: 30 days
Cardiac Index (CI)
time frame: 6 months
Cardiac Index (CI)
time frame: 12 months
Cardiac Index (CI)
time frame: 24 months
Cardiac Index (CI)
time frame: 3 years
Cardiac Index (CI)
time frame: 4 years
Cardiac Index (CI)
time frame: 5 years

Eligibility Criteria

Male or female participants at least 20 years old.

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 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.

Additional Information

Official title A Prospective, Multi-Center, Single-Arm Clinical Evaluation of the AVJ-514 System for the Treatment of Symptomatic Chronic Severe Mitral Regurgitation
Principal investigator Ryohei Yozu, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Abbott Vascular.