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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Baylor Research Institute
Updated on 4 December 2022

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.

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)

Details
Condition Mitral Annular Calcification
Treatment Mitral Valve Replacement with Sapien3
Clinical Study IdentifierNCT02830204
SponsorBaylor Research Institute
Last Modified on4 December 2022

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note