Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT02830204
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)
Study:
NCT02830204
Study Brief:
Protocol Section:
NCT02830204