Clinical Trial: Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
Brief 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.
Detailed Summary:
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 > 1
Sponsor: Baylor Research Institute
Current Primary Outcome:
- Procedural success [ Time Frame: 30 days ]
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)
- Technical success [ Time Frame: Procedure Stop Time ]
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
- Device success [ Time Frame: 30 days ]
Device Success is defined as:
- Ali
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Device success [ Time Frame: 6 months ]
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)
- Device Success [ Time Frame: 1 year ]
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)
- Subject success [ Time Frame: 1 year ]
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)
Original Secondary Outcome: Same as current
Information By: Baylor Research Institute
Dates:
Date Received: May 4, 2016
Date Started: April 2016
Date Completion: December 2018
Last Updated: November 15, 2016
Last Verified: November 2016
- Device success [ Time Frame: 6 months ]
- Ali
- Procedural success [ Time Frame: 30 days ]