Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-20 @ 5:54 AM
Study NCT ID:
NCT02830204
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2016-05-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
Sponsor:
Baylor Research Institute
Organization:
Study Overview
Official Title:
Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SITRAL
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 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)
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)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: