NCT02830204

Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Mitral Annular Calcification

Interventions

Type	Name	Description
DEVICE	Mitral Valve Replacement (MVR) with Sapien3	subjects with surgical MVR with Sapien3

Timeline

• Start date: 2016-11-04
• Primary completion: 2023-01-03
• Completion: 2023-11-29
• First posted: 2016-07-12
• Last updated: 2025-02-24
• Results posted: 2025-02-24

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study