N/A
Completed N=1,001
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
Symptomatic Degenerative Aortic Stenosis · Aortic Stenosis
Source: ClinicalTrials.gov NCT03752866 ↗
Enrolled (actual)
1,001
Serious AEs
70.5%
Results posted
Oct 2024
Primary outcomePrimary: Cardiovascular Mortality — 15; 6 Participants
Summary
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiovascular Mortality |
15; 6 | — |
| SECONDARY Number of Subjects With Myocardial Infarction |
2; 1 | — |
| SECONDARY Number of Subjects With Stroke |
8; 10; 5; 6 | — |
| SECONDARY Number of Subjects With Bleeding Events |
16; 18; 26; 33; 31; 20 | — |
| SECONDARY Number of Subjects With Acute Kidney Injury |
4; 5; 0; 3; 7; 4 | — |
| SECONDARY Number of Subjects With Vascular Complications |
32; 41; 36; 25 | — |
| SECONDARY Number of Subjects With Annular Rupture |
2; 1 | — |
| SECONDARY Number of Subjects With Coronary Obstruction |
2; 3 | — |
| SECONDARY Number of Subjects Undergoing Conversion To Open Surgery |
3; 3 | — |
| SECONDARY Number Of Subjects Undergoing Transcatheter Valve-In-Valve Deployment |
3; 6 | — |
| SECONDARY Number Of Subjects With Valve Embolization |
6; 7 | — |
| SECONDARY Number Of Subjects Undergoing Naïve Permanent Pacemaker Insertion |
87; 84 | — |
| SECONDARY Vessel Diameter |
7.42; 7.09 | — |
| SECONDARY Introducer Sheath Used |
469; 120 | — |
| SECONDARY Implant Success |
488; 488 | — |
| SECONDARY Effective Orifice Area |
1.85; 1.80 | — |
| SECONDARY Aortic Valve Mean Gradient |
7.38; 6.80 | — |
| SECONDARY Number of Subjects With Paravalvular Leak (PVL) |
185; 158; 188; 221; 9; 7 | — |
| SECONDARY NYHA Classification |
152; 159; 218; 254; 58; 42 | — |
| SECONDARY EQ5D-3L Visual Analog Scale Value |
66.5; 66.0 | — |
| SECONDARY Kaplan-Meier Rate of All-cause Mortality |
13.7; 11.0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who are ≥18 years of age or legal age in host country and have been identified as a candidate for a Portico™ valve implant
- Subjects who have been informed of the nature of the study, agree to its provisions and have provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical center
Exclusion Criteria
- Have sepsis, including active endocarditis
- Have any evidence of left ventricular or atrial thrombus
- Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
- Have a non-calcified aortic annulus
- Have congenital bicuspid or unicuspid leaflet configuration
- Are unable to tolerate antiplatelet/anticoagulant therapy
- Are pregnant at the time of signing informed consent
- Are currently participating in a drug or device study that may impact the registry (unless prior sponsor approval for co-enrollment is granted)
Data sourced from ClinicalTrials.gov (NCT03752866). 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.