N/A
Completed N=88
Behavior of Valve Leaflets Following Aortic Valve Implant
Source: ClinicalTrials.gov NCT03200574 ↗Enrolled (actual)
88
Serious AEs
43.2%
Results posted
Dec 2023
Primary outcomePrimary: Reduction in Leaflet Motion — 12 Participants
Summary
This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Leaflet Motion |
12 | — |
| SECONDARY Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes |
11; 1 | — |
| SECONDARY Reduced Leaflet Motion Through 4D Volume-rendered CT Scan |
2 | — |
| SECONDARY Reduction in Leaflet Motion by Relationship to Devices or Procedure |
12; 1; 3; 4; 4; 5 | — |
| SECONDARY Freedom From All-cause Mortality |
84 | — |
| SECONDARY Freedom From Valve Re-intervention |
88 | — |
| SECONDARY Freedom From Myocardial Infarction |
88 | — |
| SECONDARY Freedom From Structural Valve Deterioration |
88 | — |
| SECONDARY Freedom From Moderate or Severe Valve Regurgitation |
88 | — |
| SECONDARY Freedom From Valve Endocarditis |
88 | — |
| SECONDARY Freedom From Valve Thrombosis |
87 | — |
| SECONDARY Freedom From Thromboembolic Events |
82 | — |
| SECONDARY Freedom From Hemolysis |
88 | — |
| SECONDARY Freedom From Major Bleeding |
85 | — |
| SECONDARY New York Heart Association (NYHA) Assessment |
52; 17; 0; 0 | — |
| SECONDARY Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE) |
22.6 | — |
| SECONDARY Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE) |
12.5 | — |
| SECONDARY Effective Orifice Area Through Transthoracic Echocardiogram (TTE) |
1.7 | — |
| SECONDARY Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) |
51; 4; 9; 1; 3 | — |
| SECONDARY Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) |
60; 2; 5; 1 | — |
| SECONDARY Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE) |
60; 1; 6; 1 | — |
Eligibility Criteria
Inclusion Criteria
- The subject has been successfully implanted with a commercially approved LivaNova bioprosthetic valve according to the instructions for use (IFU)
- The subject has signed the informed consent.
- The subject is at least 18 years of age at the time of implant and consent signature
- The subject will be available for post-operative follow-up through one year
Exclusion Criteria
- The subject has a planned concomitant cardiac procedure other than coronary artery bypass graft (CABG) and septal myectomy, including MAZE procedures, atrial fibrillation surgery, and left atrial appendage exclusion or resection, or has a prosthetic heart valve or annuloplasty ring in any position
- The subject has any medical condition requiring long term (> 6 months) anticoagulation or dual antiplatelet therapy
- The subject has any clinical condition precluding the use of CT imaging with contrast
- The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of the planned valve implant surgery
- The subject has active endocarditis, myocarditis, or sepsis
- The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support
- The subject is already included in another clinical trial that could confound the results of this clinical investigation
Data sourced from ClinicalTrials.gov (NCT03200574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.