Clinical Trial: Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis
Brief Summary: The primary objective of the present trial is to demonstrate the effectiveness and safety of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects deemed difficult for surgical operation.
Detailed Summary: Non-randomized, prospective, multicenter, single-arm trial.
Sponsor: Medtronic Cardiovascular
Current Primary Outcome: Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA). [ Time Frame: baseline and 6 months ]
Original Primary Outcome: Change in composite score of New York Heart Association (NYHA) Class and effective orifice area (EOA). [ Time Frame: baseline and 6 months ]
Current Secondary Outcome:
- NYHA Classification Over Time [ Time Frame: 30 days ]
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
- NYHA Classification Over Time [ Time Frame: 6 months ]
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
- NYHA Classification Over Time [ Time Frame: 12 Months ]
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.
Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
- NYHA Classification Over Time [ Time Frame: 24 Months ]
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.
Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
- NYHA Classification Over Time [ Time Frame: 36 Months ]
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.
Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physica
Original Secondary Outcome:
- Change in NYHA classification from baseline. [ Time Frame: baseline and 30 days, 6 months, 12 months, and annually thereafter up to five years ]
- The occurrence of individual Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) components [ Time Frame: 5 years ]
MACCE is defined as a composite of:
- all-cause death
- myocardial infarction (MI)
- all stroke, and
- reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
- Device Success as Defined in the Description. [ Time Frame: from admission for procedure to discharge, on average less than 1 week ]
- successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system
- correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function)
- Intended performance of the prosthetic valve (aortic valve area >1.2 cm² (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve AR)
- Only one valve implanted in the proper anatomical location
- Procedural Success, Defined as Device Success and Absence of In-hospital MACCE. [ Time Frame: from admission for procedure to discharge, on average less than 1 week ]
- Echocardiographic assessment of prosthetic valve performance [ Time Frame: 5 years ]Measured by transvalvular mean gradient, effective orifice area, degree of aortic valve regurgitation (transvalvular and paravalvular), left ventricular ejection fraction (LVEF).
- Repeat hospitalization [ Time Frame: 5 years ]
- Valve-related deaths [ Time Frame: 5 years ]
- All adverse events [ Time Frame: 5 years ]
- Quality of Life assessment using SF-36 questionnaire. [ Time Frame: 5 years ]
Information By: Medtronic Cardiovascular
Dates:
Date Received: September 16, 2011
Date Started: October 2011
Date Completion: July 2018
Last Updated: April 5, 2017
Last Verified: April 2017
