ONGOING RESEARCH FOR BETTER EVIDENCE

The Amulet occluder is delivered in a minimally invasive transcatheter approach through a femoral venous puncture. The Amulet occluder is introduced to the left atrium via an interatrial transseptal puncture. The lobe secures the Amulet occluder within the left atrial appendage, while the disc completely seals the appendage at the orifice.

Key Inclusion Criteria

• Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)
• At high risk of stroke or systemic embolism, defined as a CHA₂DS₂-VASc score of ≥ 3 for women and ≥ 2 for men
• Eligible for long-term NOAC therapy

Key Exclusion Criteria

• Requires long-term OAC therapy for a condition other than AF
• Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use
• Has undergone atrial septal defect (ASD) repair or has an ASD closure device present 
• Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted 

*Additional inclusion and exclusion criteria as listed on ClinicalTrials.gov

The CATALYST Trial is a prospective, randomized, multicenter active control worldwide trial. Subjects are randomized in a 50/50 ratio between the Amulet LAA occlusion device and a commercially available NOAC blood thinner medication.

• Composite of ischemic stroke, systemic embolism, or CV mortality
• Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events
• Composite of ischemic stroke or systemic embolism
   

Through transfemoral, subclavian or axillary access methods, the Navitor™ Valve will be introduced in the patient’s body using the FlexNav™ Delivery System. The delivery system design facilitates gradual, controlled deployment of the valve. Controlled movement of the sheath will be viewed through cardiac fluoroscopic imaging. Predilate the native aortic valve with an appropriate diameter valvuloplasty balloon. Once the sheath is in position, the Navitor Valve will be delivered and placed within the opened aortic valve (Figure 1). The Navitor Valve is deployed annulus end first from the distal end of the delivery system (Figure 2). If needed, the valve may be resheathed and repositioned up to two times, provided the valve has not been fully deployed. Once the Navitor Valve has been released from its delivery system, it will start functioning. The delivery system will be removed from the patient’s body, and the incision will be closed.

Key inclusion criteria

• Subject is deemed to be at low or intermediate risk for open surgical aortic valve replacement (risk of surgical mortality < 7% at 30 days, considering The Society of Thoracic Surgeons (STS) risk score, overall clinical status, and other clinical comorbidities unmeasured by the risk calculator)
• New York Heart Association (NYHA) Functional Classification of II, III or IV
• Senile degenerative aortic valve stenosis with ECHO-derived criteria, which is defined as aortic valve area (AVA) of ≤ 1.0 cm² (or indexed effective orifice area (EOA) ≤ 0.6 cm²/m²) and either mean gradient ≥ 40 mmHg or peak jet velocity ≥ 4.0 m/s or Doppler velocity index (DVI) ≤ 0.25
• Aortic annulus diameter of 19–30 mm and ascending aorta diameter of 26–44 mm for the specified valve size listed in the Instructions for Use (IFU), as measured by computerized tomography (CT) conducted within 12 months prior to informed consent

Key exclusion criteria

• Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or transient ischemic attack (TIA)Renal insufficiency (creatinine > 3.0 mg/dL or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²) and/or end-stage renal disease requiring chronic dialysis
• Need for emergency surgery for any reason
• Hostile chest or conditions or complications from prior surgery that would make the patient be considered high surgical risk
• Significant frailty as determined by the heart team (after objective assessment of frailty parameters) that would indicate high or extreme surgical risk
• Evidence of an acute myocardial infarction within 30 days prior to index procedure
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3–4+)
• Aortic valve is a congenital unicuspid or congenital bicuspid valve as verified by echocardiography and computerized tomography
• Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 30%, as measured by resting echocardiogram
• Non-calcified aortic valve

*Additional inclusion and exclusion criteria as listed on ClinicalTrials.gov

This is a prospective, randomized, controlled, multicenter, investigational clinical study of approximately 1,500 patients at up to 80 medical centers in the United States and up to 15 medical centers outside of the United States. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.  Subjects in this clinical investigation will be randomized between the Navitor TAVI System (test arm) and any commercially available TAVI system (control arm) in a 1:1 ratio.

Primary endpoint

Composite of all-cause mortality or all stroke at 12 months

TriClip TEER is a minimally invasive transcatheter procedure performed on a beating heart in a standard cath lab or hybrid room. The TriClip™ Delivery System is anatomically designed for direct access to the tricuspid valve via the right atrium. The following steps provide a general overview of the TriClip TEER procedure.

Key inclusion criteria

Subjects must meet all of the following inclusion criteria in order to participate in the trial:

• In the judgment of the site’s local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows:
  • Optimized medical therapy for treatment of TR (eg, diuretics)
  • Medical and/or device therapy for mitral regurgitation, atrial fibrillation, coronary artery disease, and heart failure
• The eligibility committee (EC) will confirm that the subject has been adequately treated medically
• Subject is symptomatic with severe TR despite being optimally treated as described above. TR severity is determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s)
• The cardiac surgeon of the Site Heart Team concurs that the patient is at intermediate or greater estimated risk of mortality with tricuspid valve surgery
• New York Heart Association (NYHA) Functional Class II, III, or ambulatory class IV

Key exclusion criteria

• Systolic pulmonary artery pressure (sPAP) > 70 mm Hg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC)
• Severe uncontrolled hypertension (systolic blood pressure [SBP] ≥ 180 mm Hg and/or diastolic blood pressure [DBP] ≥ 110 mm Hg)
• Indication for left-sided (eg, severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction in the prior 60 days
• Left ventricular ejection fraction (LVEF) ≤ 20%
• Pacemaker or implantable cardioverter defibrillator (ICD) leads that would prevent appropriate placement of the TriClip™ device
• Any prior tricuspid valve procedure that would interfere with placement of the TriClip™ device
• Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets, or sufficient reduction in TR. This may include:
  • Evidence of calcification in the grasping area
  • Presence of a severe coaptation defect (> 2 cm) of the tricuspid leaflets
  • Severe leaflet defect(s) preventing proper device placement
  • Ebstein anomaly
• Tricuspid valve stenosis (tricuspid valve orifice of ≤ 1.0 cm² and/or mean gradient ≥ 5 mm Hg as measured by the ECL)
• Tricuspid valve anatomy not evaluable by TTE and TEE

*Additional inclusion and exclusion criteria as listed on ClinicalTrials.gov

Primary Endpoint:

To be assessed after the first 350 randomized subjects complete 12-month follow-up.
A composite of mortality or tricuspid valve surgery, heart failure hospitalizations, and quality of life improvement ≥15 points assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ), evaluated at 12 months in a hierarchical fashion using the Finkelstein-Schoenfeld methodology.

Secondary Endpoints:

Assessed hierarchically in the following order:

1. Freedom from major adverse events (MAE) after procedure attempt (femoral vein puncture) at 30 days (Device group only)
2. Change in KCCQ at 12 months (superiority of Device vs. Control)
3. TR Reduction to moderate or less at 30-day post procedure (superiority of Device vs. Control)
4. Change in 6MWD at 12 months (superiority of Device vs. Control)