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

• ClinicalTrials.gov Identifier: NCT02830204
• Recruitment Status: Active, not recruiting
• First Posted: July 12, 2016
• Last Update Posted: February 21, 2023
• Sponsor: Baylor Research Institute
• Collaborator: Edwards Lifesciences
• Information provided by (Responsible Party): Baylor Research Institute

Tracking Information

• First Submitted Date: May 4, 2016
• First Posted Date: July 12, 2016
• Last Update Posted Date: February 21, 2023
• Actual Study Start Date: September 2016
• Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 8, 2016)

• Procedural success [ Time Frame: 30 days ]
  Procedural Success is defined as:

  1. Device success, and
  2. 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:

  1. Alive, with
  2. Successful access, delivery and retrieval of the device delivery system, and
  3. Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and
  4. 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:

  1. Alive and stroke free, with
  2. Original intended device in place, and
  3. 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
  4. Intended performance of the device:
     1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
     2. 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
     3. 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 8, 2016)

• Device success [ Time Frame: 6 months ]
  Device Success is defined as:

  1. Alive and stroke free, with
  2. Original intended device in place, and
  3. 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
  4. Intended performance of the device:
     1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
     2. 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
     3. 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:

  1. Alive and stroke free, with
  2. Original intended device in place, and
  3. 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
  4. Intended performance of the device:
     1. Structural performance: No migration, embolization, detachment, fracture, hemolysis, thrombosis (including reduced leaflet motion) or endocarditis, etc, and
     2. 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
     3. 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 Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Surgical Implantation of TRAnscatheter vaLve in Native Mitral Annular Calcification (SITRAL) Study
• 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 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Mitral Annular Calcification

Intervention

Device: Mitral Valve Replacement with Sapien3

subjects with surgical MVR with Sapien3

Other Name: MVR

Study Arms

Experimental: Mitral Valve Replacement with Sapien3

subjects with surgical MVR with Sapien3

Intervention: Device: Mitral Valve Replacement with Sapien3

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 8, 2016): 30
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: September 2023
• Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subject has severe native mitral annular calcification associated with mitral stenosis and/or regurgitation. Qualifying echo must be within 60 days of the date of the procedure.
• Subject has a clinical indication for mitral valve replacement, as demonstrated by reported New York Heart Association (NYHA) Functional Class II or greater.
• The subject is at least 22 years old.
• The Heart Team agrees that the subject is high risk or inoperable for surgical mitral valve repair or replacement (MVR), based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. The following concomitant procedures, are allowed: MAZE, Tricuspid Valve Procedures (TVP), and Atrial Fibrillation (AF) ablation, coronary artery bypass grafting and septal myectomy.
• The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
• The study subject agrees to comply with all required post-procedure follow-up visits

Exclusion Criteria:

• Evidence of an acute myocardial infarction (MI) ≤ 30 days before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
• Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease).
• Leukopenia (white blood cell count < 2000 cell/mL), acute anemia (hemoglobin < 8 g/dL), or thrombocytopenia (platelet count < 50,000 cell/mL).
• Hemodynamic or respiratory instability requiring vasoactive medications, mechanical ventilation at time of procedure.
• Need for emergency surgery for any reason.
• Severe left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) < 30%.
• Severe right ventricular dysfunction
• Pregnancy, lactation, or planning to become pregnant
• Echocardiographic evidence of left ventricular mass, thrombus, or concerns of active infective endocarditis.
• Active upper gastrointestinal (GI) bleeding within 3 months prior to procedure without treatment or 30 days prior to procedure with definitive treatment.
• A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be maintained on oral anticoagulant following the study procedure.
• End stage renal disease requiring dialysis
• Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 30 days of the procedure.
• Estimated life expectancy < 12 months

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02830204
• Other Study ID Numbers: 016-100
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: There is currently no plan to share individual participant data

• Current Responsible Party: Baylor Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Baylor Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Edwards Lifesciences

Investigators

• Principal Investigator: Robert Smith, MD; Baylor Research Institute

• PRS Account: Baylor Research Institute
• Verification Date: February 2023